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faq

Why is the VIDPRESAE study being conducted?

What is Vitamin D?

How many children will take part in the VIDPRESAE study?

Who is eligible to participate in the VIDPRESAE study?

What happens during the VIDPRESAE study?

Are there any costs or benefits to participating in the VIDPRESAE study?

What is Spirometry?

Why should my child participate in the SIENA study?

Are there any costs or benefits to participating in the SIENA study?

Who is eligible to participate in the SIENA study?

What is Albuterol reversibility in BARD?

Why should my child participate in the BARD study?

Who is eligible to participate in the STICS study?

What happens during the STICS study?

What is Spirometry?

What is Albuterol reversibility in SIENA?

How many children will take part in the STICS study?

Why is the STICS study being conducted?

Why should my child participate in the VIDPRESAE study?

Why is the SIENA study being conducted?

Why should my child participate in the STICS study?

What happens during the SIENA study?

What is sputum induction?

What is exhaled nitric oxide?

Are there any costs or benefits to participating in the STICS study?

How many people will take part in the SIENA study?

What is a methacholine challenge test?

Are there any costs or benefits to participating in the BARD study?

Who is eligible to participate in the BARD study?

What happens during the BARD study?

Why is the BARD study being conducted?

How many children will take part in the BARD study?

What is sputum induction?

Will my child be paid for taking part in this study?

What are the costs of taking part in this study?

What will happen if my child takes part in this research study?

What is the LIMB Study?

What is involved in DIMES participation?

What do I need to do to participate before I deliver?

What do I need to do after I deliver?

What will I do after I go home?

What will the study staff do?

What else is involved in participating in TIPS?

What are the participant benefits?

Who is eligible to participate in the PACK study?

How will the study protect our baby?

What will you do with the information gathered?

What will happen if I participate in the PACK study?

Why do you collect stool?

Is there compensation for participating in the PACK study?

What is Excessive Fussiness?

What do you collect during the blood draw?

What happens during the skin prick test?

I want to participate, but I am not sure about the blood draws or skin prick test.

What are Probiotics?

How do Probiotics work?

What type of Probiotic does the TIPS study use?

Why is the APPUC study being done?

Who is conducting the APPUC study?

Who is eligible to participate in the APPUC study?

What probiotic is being used in the PACK study?

Why is the APRIL study being conducted?

What is wheezing?

How many children are taking part in the APRIL study?

Who is eligible to participate in the G-RAFS study?

What will happen if I participate in the G-RAFS study?

Is there compensation for participating in the G-RAFS study?

What are Synbiotics?

What synbiotic is being used in this study?

Why is the VIDPRESAE study being conducted?



Asthma is a major public health problem in the United States and worldwide.  For unclear reasons, there has been an increase in asthma from 1960 to at least the 1990s.


This research study will look at your child’s asthma in relation to vitamin D deficiency and asthma “flare ups”. It is hoped that information gained from this study may help us find out if vitamin D can actually protect against flare-ups of asthma symptoms

What is Vitamin D?


Vitamin D is a nutrient that is part of a healthy diet.  Vitamin D is important for strong bones.  People who do not get enough vitamin D can develop soft or brittle bones, a condition also called ‘rickets.’ 

Vitamin D is also important for fighting infection, helping nerves carry messages from the brain to the body and also helping the muscles move well. 

How many children will take part in the VIDPRESAE study?


400 Children will participate in the VIDPRESAE study across two study sites, San Francisco, CA and Pittsburgh, PA . At UCSF and SFGH 200 children will be enrolled.

Who is eligible to participate in the VIDPRESAE study?

We are actively recruiting for this study!  If you would like to learn more please contact the study team at 1-866-913-8477 or by email at .(JavaScript must be enabled to view this email address).
Your child may be eligible to participate if he or she is:
• 6-14 years old, has been diagnosed with asthma, AND
• has been taking asthma controller medication daily for at least 6 months.

What happens during the VIDPRESAE study?

Children who qualify to participate will be randomly selected to receive a daily oral Vitamin D supplement or placebo for approximately 1 year. During that year we will ask you to bring your child to approximately 9 study visits, the visits will include Vit D testing, respiratory tests and questionnaires about your child’s asthma.

Are there any costs or benefits to participating in the VIDPRESAE study?

There are no costs to participate in the VIDPRESAE study. All study medications will be provided at no charge. Participants will have their Vitamin D and Calcium level checked at no charge. Study participation includes breathing tests and asthma advice from asthma physicians. Families can contact the study coordinators or the on call physician if the have any questions regarding their child’s asthma. Families will be compensated for their time depending of how long each visit takes, 30 dollars for the 1st hour and 20 dollars for every hour after the first one.

What is Spirometry?

Spirometry is a test that measures the amount of air blown out of the lungs and how fast it comes out. During the test, your child will wear a nose clip, take a big breath in and then blow out all their air hard and fast into a machine called a spirometer. You child will be asked to blow into the spirometer several times. This test tells us how well your child’s lungs are working and will be done at each visit.

Why should my child participate in the SIENA study?

Your child’s asthma may or may not improve while in this study. However, the results of this study will help doctors learn more about treating children with asthma in the future. We will give you information about asthma and about staying away from asthma triggers. Your child will receive care from asthma physicians. Your child’s participation could help others with asthma.

Are there any costs or benefits to participating in the SIENA study?

There are no costs to participate in the SIENA study. All study medications will be provided at no charge. Study participation includes breathing tests, asthma medication, and asthma advice from asthma physicians.  There is compensation up to $1,082-$1,267 (if you complete the study). Participants will receive free asthma education.

Who is eligible to participate in the SIENA study?

We are actively recruiting for this study!  If you would like to learn more please contact the study team at 1-866-913-8477 or by email at .(JavaScript must be enabled to view this email address).

Your child may be eligible to participate if he or she is:
12-17 years old and has asthma.

What is Albuterol reversibility in BARD?

This test measures improvement in your child’s breathing. Your child will perform spirometry, take 4 puffs of albuterol, and repeat spirometry 15 minutes later. It will be done 5 times during the study to see if the study treatments change your child’s results.

Why should my child participate in the BARD study?

Your child’s asthma may or may not improve while in this study. However, the results of this study will help doctors learn more about treating children with asthma in the future. We will give you information about asthma and about staying away from asthma triggers. Your child will receive care from asthma physicians. Your child’s participation could help others with asthma.

Who is eligible to participate in the STICS study?

We are actively recruiting for this study!  If you would like to learn more please contact the study team at 1-866-913-8477 or by email at .(JavaScript must be enabled to view this email address).

Your child may be eligible to participate your child:

• is 5-11 years old
• takes an everyday controller medication for their asthma or recently had asthma symptoms
• had at least one course of oral steroids for asthma symptoms in the last year

What happens during the STICS study?

Most people with asthma use an action plan to guide their asthma treatment. Written asthma action plans are usually color-coded. “Green” means that asthma symptoms are well controlled. “Yellow” means that asthma symptoms are not well controlled and asthma treatment may need to change. “Red” means a severe worsening of symptoms. Red zone treatment is usually an oral corticosteroid like prednisone.

Participants will take an inhaled corticosteroid (Fluticasone), 2 puffs twice a day while asthma symptoms are in the green zone, and will be randomly assigned to one of two yellow zone treatments which are:

1. Continue the same dose of daily corticosteroid treatment for 7 days

2. Increase the daily corticosteroid dose for 7 days

There will be 8 visits to our research center and 6 telephone calls over 1 year. Participants will receive asthma tests and asthma medications at no charge.

What is Spirometry?

Spirometry measures how much air you blow out of your lungs and how fast it comes out. During the test, you will wear a nose clip, take a big breath in and then blow out all your air hard and fast into a machine called a spirometer. You will be asked to blow into the spirometer several times. This test tells us how well your lungs are working and will be done at each visit.

What is Albuterol reversibility in SIENA?

This test measures improvement in your breathing. You will perform spirometry, take 4 puffs of albuterol, and repeat spirometry 15 minutes later. If you show at least 12% improvement in spirometry after 4 puffs of albuterol, a methacholine challenge test will not take place.

How many children will take part in the STICS study?

UCSF is one of 9 clinical research centers in the country doing this study. A total of about 250 children will be in this study nationwide. At least 25 children will be included in the study at UCSF.

Why is the STICS study being conducted?

The purpose of this study is to improve the asthma guidelines primary care doctors use when treating asthma in children. The study aim is to find the best action plan strategy for children with asthma during asthma flare ups. Finding the best treatment strategy may prevent symptoms from increasing to a severe exacerbation requiring oral corticosteroids, like prednisone. The study is also trying to determine which treatment strategy leads to the least total corticosteroid (oral and inhaled) use for children with asthma.

We are studying whether in children receiving low-dose daily controller medication for their asthma, stepping up that therapy when a child begins to have an asthma flare-up will reduce the likelihood of a severe asthma exacerbation.

Why should my child participate in the VIDPRESAE study?

This study may or may not help your child’s asthma, but participation will help the medical community better understand the effects of Vitamin D levels in children with asthma. Your child’s participation could help others with asthma.

Why is the SIENA study being conducted?

The purpose of this study is to find out if people should take an asthma controller medication based on the type of cells present in their airway. We will examine the response to inhaled corticosteroid, which is the standard treatment, and tiotropium, an inhaled medication that has been FDA-approved for COPD (Chronic Obstructive Pulmonary Disease, a smoking related disease that is similar to asthma) but not for asthma, in participants with different types of airway inflammation.

Why should my child participate in the STICS study?

Your child’s asthma may or may not improve while in this study. However, the results of this study will help doctors learn more about personalizing asthma treatment in the future. We will give you information about asthma and about staying away from asthma triggers. Your child will receive care from asthma physicians, asthma tests, and medications at no cost. Your child’s participation could help others with asthma.

What happens during the SIENA study?

6 study visits and 6 phone contacts over 36 weeks.

Study participation includes asthma tests and lung sputum testing.

If you pass the run-in, you will be given two inhalers. One inhaler is either an inhaled steroid or placebo. The other inhaler is either a long-acting muscarinic antagonist or placebo. Inhalers are described in detail below.

Each person will have 12 weeks on each of the three possible study treatments. The order of these treatments will be decided randomly, like flipping a coin. You and the study staff will not know which treatment you are getting. The treatments include:

1. active mometasone plus placebo tiotropium
2. placebo mometasone plus active tiotropium
3. placebo mometasone plus placebo tiotropium

What is sputum induction?

Your child will take 4 puffs of albuterol before this spit test to open the breathing tubes. Then, your child will be asked to breathe in a salty mist for up to 12 minutes. Every two minutes your child will be asked to cough deeply and strongly in order to bring up mucus (also known as sputum). This test will be done 1 time.

What is exhaled nitric oxide?

The amount of nitric oxide in your breath is thought to increase when the lungs are irritated or inflamed. You will be asked to slowly blow into a mouthpiece attached to a machine that measures nitric oxide.

Are there any costs or benefits to participating in the STICS study?

There are no costs to participate in the STICS study. All study medications will be provided at no charge. Your child will have breathing tests and advice from study doctors who are asthma experts. Your child’s participation will help the medical community understand better ways to treat people with asthma using personalized treatment plans. You will gain satisfaction knowing that your participation could help others with asthma.  There will be study compensation (up to $600 if you complete the entire study).

How many people will take part in the SIENA study?

384 people across the nation will participate in the SIENA study.  Up to 45 people can be enrolled at UCSF

What is a methacholine challenge test?

Methacholine is a medication that can cause narrowing of the airways of the lung. During a methacholine challenge, participants breathe in gradually increasing doses of methacholine. Spirometry will be performed after each dose of methacholine. The test will stop once spirometry show your airways narrow by 20% or you have been given the last dose. You may have mild asthma symptoms during this test. You will receive albuterol to make these symptoms go away.

Are there any costs or benefits to participating in the BARD study?

There are no costs to participate in the BARD study. All study medications will be provided at no charge. You will have breathing tests and advice from study doctors who are asthma experts. You will help the medical community understand better ways to treat people with asthma using personalized treatment plans. You will gain satisfaction knowing that your participation could help others with asthma.  There will be study compensation (up to $1368 if you complete the entire study).

Who is eligible to participate in the BARD study?

We are actively recruiting for this study!  If you would like to learn more please contact the study team at 1-866-913-8477 or by email at .(JavaScript must be enabled to view this email address).

Your child may be eligible to participate if he or she:

• is 5-17 years old
• has asthma symptoms despite asthma treatment.
• of African American/Black ancestry (have at least one African American/Black grandparent)

What happens during the BARD study?

Study participation will last up to 16 months.  During this time there will be 15-18 visits to our research center and 10 brief telephone calls.  Study visits will include asthma tests, study medications, and blood/urine tests at no charge. Participants will be taught how to recognize worsening asthma symptoms though a personalized asthma action plan.

If your child is enrolled in the study, they will stop taking their regular asthma medication and receive the four different study treatments in random order:

1. Combined low dose fluticasone plus salmeterol
2. Low dose fluticasone alone
3. Combined medium dose fluticasone plus salmeterol
4. Medium dose fluticasone alone

Why is the BARD study being conducted?

The purpose of this study is to find the best asthma treatment to add for African American/Black children who have asthma that is not well controlled on a low dose of inhaled steroid. We are comparing four different treatments for asthma. This study will also try to find out if African American/Black adults and children differ in how they respond to the medications used in this study.

How many children will take part in the BARD study?

As many as 1000 people across the nation may need to be screened so that 494 can take part in the study. Up to 50 children may take part at the UCSF partnership.

What is sputum induction?

This screening procedure tells us which cells are in your airway. You will receive 4 puffs of albuterol before this procedure to open your airways. You will be asked to breathe in a salty mist for up to 12 minutes. Every two minutes you will be asked to cough deeply and vigorously in order to bring up a sample of sputum (mucus from your airway).

Will my child be paid for taking part in this study?

Your child will be given a $25 gift card when he/she has completed the study protocol.
For the complete list of FAQs, please see the consent forms under Study Documents

What are the costs of taking part in this study?

You will not be charged for any of the tests done for this study.

What will happen if my child takes part in this research study?

1)    On the morning preceding your child’s visit, your child will collect a first-morning urine sample, after an 8-12 hour overnight fast, as you and your child will be instructed. You will bring in your child’s frozen sample as instructed.
2)    You and your child will be asked to answer questions about your child’s medical history. Your child will fill out a form that has drawings on it to evaluate your child’s physical development. You can help your child fill it out.
3)    Your child’s height and weight will be measured. You and your child will meet with a dietician for your child’s nutrition assessment, including collection of your child’s dietary intake and history, and skin fold and arm and waist circumference measurements. Several weeks after the visit, you and your child will receive results of the dietary analysis.
4)    Your child will have blood drawn, which will include hormone levels. If your child has abnormal hormone levels, your child’s pediatric gastroenterologist will contact the pediatric endocrinologist. If necessary, your child will be referred to the pediatric endocrinologist as part of his/her routine care.
5)    Your child will have an x-ray of his/her left hand in radiology. This is to determine your child’s bone age.
6)    Your child’s doctors may need to review his/her medical records to clarify information you and your child give them during the visit.
       
All study procedures will be done at the UCSF Benioff Children’s Hospital at the University of California in San Francisco. Participation in this study will take about 90 minutes to 2 hours.
This study involves only ONE visit.

What is the LIMB Study?

The goal of this study is to identify genetic enhancers that are important for limb development as well as identify mutations in these enhancers that could be responsible for isolated limb malformations.

What is involved in DIMES participation?

We will collect stool samples during the first year of your child’s life and conduct telephone surveys.Your baby will be seen by our research nurse for one targeted physical exam at UCSF when he/she is 12 months of age. During this visit we will ask your permission to collect a blood sample.

What do I need to do to participate before I deliver?

Schedule an appointment with a research coordinator to complete a consent form and questionnaires .

What do I need to do after I deliver?

  1. Call us to let us know that you have delivered.
  2. Complete a second consent form for your baby to participate. This will allow a member of the research team to review your delivery records and examine your baby to be sure he/she is eligible.

What will I do after I go home?

  1. You will give the supplement to your baby once a day for 6 months. It is easily mixed in breast milk, formula, or water, and is given using a small size oral medicine syringe.
  2. You will keep track of what your baby eats for the first year, along with medical visits and any medications.  We will give you forms to help keep track of these things.

What will the study staff do?

  1. After we examine your baby in the nursery, she/he will be “randomized” to either the intervention or the control group.  A randomization process (like flipping a coin) assigns your child to the active supplement (intervention) or the placebo (control group).  This means that your baby has a 50% chance of receiving the active supplement.
  2. We will provide you with everything you will need to continue participation in the study.
  3. If you will be using formula at any point during the first year, we can provide this to you.

What else is involved in participating in TIPS?

Your baby will be seen by our research nurse for targeted physical exams and a parent interview six times throughout the 3 year study. The visits will take place at home or at our UCSF Pediatric Clinical Research Center. We will call to schedule these visits at a convenient time for you.
We will complete questionnares with you on the phone in between the physical exams.
We will collect 2 stool samples at 1, 3, 6, 9 & 12 months and blood samples at 1, 2, & 3 years. A skin prick test for common allergens will be performed during the 3 year visit.

What are the participant benefits?

  • $25.00 gift cards with each physical exam visit (6 total)
  • Reimbursement for parking expenses at UCSF
  • Tote bag containing all of the study information
  • Medela Breast pump for all breastfeeding moms
  • Carnation Good Start Supreme formula for all formula fed babies (up to 1 year of age)
  • Targeted monitoring for early markers of asthma, eczema and allergies
  • Access to asthma experts
  • Free skin prick testing for allergies
  • Lab results sent to your child’s pediatrician

Who is eligible to participate in the PACK study?

You may be eligible if:

  • Your baby was a healthy, full term baby
  • Your baby is between 3 weeks and 4 months old
  • You are currently formula feeding your baby
  • Your baby experiences crying or fussiness that totals 3 hours per day, 3 times per week for at least one week

How will the study protect our baby?

A special committee of research and medical professionals (called the Data Safety Monitoring Board) looks at the information collected throughout the study to see if there are any problems experienced by the study subjects.  The only goal of this committee is to protect participants.

What will you do with the information gathered?

After all the study information has been collected, the type of supplement (active or inactive) received by each infant will be made known to the research team. We can then analyze the data to see if the active supplement prevented or delayed the appearance of the early signs of asthma.

What will happen if I participate in the PACK study?

Participation lasts 28 days (1 month).  Three study visits which take place in your home are arranged to fit your schedule.  If you decide to participate in the study you will be asked to:

  • Give your baby the study’s formula for 1 month
  • Keep a diary of your baby’s sleeping, crying and formula feeding
  • Answer 2 phone questionnaires
  • Allow 5 study visits to occur in your home

Why do you collect stool?

We will look at the micro-flora in the stool to identify the predominant colonies in the gut. We will also quantify the various types and amounts of other bacteria found in your baby’s stool. Because we collect stool for multiple protocols, we will be able to compare all the stool information across groups to see if there are significant differences among study groups.

Is there compensation for participating in the PACK study?

There is no compensation for participation in this study.  However, participants will receive a $50 gift card at each study visit as a thank you for their time and participation.

What is Excessive Fussiness?

Babies are said to have excessive fussiness if they are healthy and well-fed but have episodes of crying or fussiness totalling 3 hours per day, more than 3 days per week.

What do you collect during the blood draw?

During a blood draw we collect about 2 teaspoons of blood. We send the blood to the lab to test serum immunoglobulin E (IgE) and run a complete blood count (CBC) with differential. We do this in order to look for early markers of asthma. Your baby’s pediatrician may also wish to collect a blood sample and we offer you the opportunity to have the results of the blood draw released to your baby’s pediatrician.

The nurses collecting the blood samples are specially trained to work with babies and are extremely gentle. It is everyone’s goal to make your baby as comfortable as possible during the blood draw.

What happens during the skin prick test?

At three years, we ask if we can perform a skin prick test. During a skin prick test, a very small drop of solution (that contains a possible allergen) is pricked on the skin using a small plastic applicator. If a raised, red, itchy area (called a wheal) appears on the skin, it indicates a possible allergic sensitivity fo that allergen.

We test for: Almonds •  Dog Hair - Dander •  Birch mix •  Cashew nut •  Cat Pelt •  Cockroach mix •  Egg White - chicken •  Egg whole - chicken •  Egg yolk - chicken •  Fish mix •  Mite D. Farinae •  Mite D. Pter.  •  Control •  Histamine •  Mold Mix •  Mountain cedar •  Peanut •  Pecan food •  Perennial rye grass •  Rice food •  Shellfish mix •  Soybean food •  Walnut food •  Whole Milk - cow •  Whole wheat.

This test is done at no cost to you and we are happy to send the results to your child’s pediatrician.

I want to participate, but I am not sure about the blood draws or skin prick test.

As a participant in a medical research study, you have the right to decline any procedure or survey question that makes you uncomfortable. However, if you plan to decline large parts of the study, please reconsider the decision to participate.

What are Probiotics?

Often called “good bacteria,” Probiotics are defined as “live microorganisms which when administered in adequate amounts confer a health benefit on the host.” Probiotics are commonly found in fermented food products such as yogurt and buttermilk. In recent years, there has been a lot of interest in the use of Probiotics for the treatment and prevention of stomach ailments (like diarrhea) and allergic diseases (like asthma and eczema).

How do Probiotics work?

The gastrointestinal tract is home to many strains of bacteria and this diverse microbial community found in our stomach is often referred to as “gut flora”. An imbalance in the gut flora may also disrupt or influence the processes of the native bacteria and cause changes in the way bacteria help digest food, causing problems. Probiotics (“good bacteria” thought to benefit the user) may keep a balanced gut flora by competing with “bad” bacteria for food so that the bad bacteria cannot replicate as easily or may help favor conditions that allow good bacteria to thrive.

What type of Probiotic does the TIPS study use?

The probiotic used in this study is Lactobacillus GG, the most researched Probiotic on the market today. The TIPS Study has chosen this strain of Probiotic for three main reasons: it is naturally derived, generally regarded as safe and is able to survive stomach acids and stick well to the intestinal tract.

Why is the APPUC study being done?

This study is being done to address disparities in childhood asthma and to improve physician-patient communication in asthma care and asthma outcomes. As an outcome of this study we will develop an additional component for the PACE program that addresses cultural competency during provider-patient interactions.

Who is conducting the APPUC study?

This program is conducted by the University of California, San Francisco’s Division of General Pediatrics and Institute for Health Policy Studies as part of the Academy for Educational Development’s National Asthma Control Initiative (NACI). Learn more about the NACI demonstration projects by clicking here.

Who is eligible to participate in the APPUC study?

You may be eligible to participate in APPUC phase II if you are an active asthma care/asthma education practitioner willing to:

1. Participate in a 1 hour web-based train-the-trainer session.

2. In partnership with asthma experts from UCSF, co-lead a 1 hour lunch presentation for other clinicians at your practice between November 2011 – February 2012.

3. Help evaluate the lunch presentation with a post-presentation survey to clinicians at your practice who attend the session.

 

What probiotic is being used in the PACK study?

The probiotic used in this study is Lactobacillus reuteri. In recent years, there has been an increased interest in the use of probiotics for the treatment and prevention of inflammatory bowel disease, and infectious and antibiotic associated diarrhea. Lower counts of the intestinal probiotic, Lactobacilli, have also been associated with colicky infants in comparison with healthy infants.

Why is the APRIL study being conducted?

Wheezing episodes in young children are a hard to treat problem and physicians lack information on the best way to treat these symptoms. Preschool aged children who develop coughing or wheezing symptoms when sick often need extra visits to the doctor’s office or hospital. The goal of this study is to provide better treatment options for children ages 1-6 with recurrent wheezing episodes.

What is wheezing?

Wheezing is a common symptom of asthma. It is a whistling sound in the chest while breathing caused by blocked airways in the lungs. Being sick can trigger wheezing symptoms because the lungs will produce thick mucus that plugs up the airways.

How many children are taking part in the APRIL study?

We are no longer recruiting for this study. Around 600 children are taking part in this study across 16 clinical centers nationwide. 62 children are taking part at UCSF and SFGH.

Who is eligible to participate in the G-RAFS study?

Your child may be eligible if:

  • Your baby was a healthy, full term baby
  • Your baby is less than 14 days old
  • You have decided to exclusively formula feed.

What will happen if I participate in the G-RAFS study?

Participation lasts 6 months.  Five study visits which take place in your home are arranged to fit your schedule.  If you decide to participate in the study you will be asked to:

  • Give your baby the study’s formula for six months.
  • Keep a diary of your baby’s mood, feeding, and diaper changes for two days before each visit.
  • Allow 5 study visits to occur in your home.

Is there compensation for participating in the G-RAFS study?

There is no compensation for participation in this study.  However, participants will receive a $25 gift card at each study visit as a thank you for their time and participation.

What are Synbiotics?

Synbiotics are a dietary supplement that contains a mixture of beneficial bacteria called probiotics and fiber that does not dissolve called prebiotics. Probiotics are live bacteria found in many foods especially in cultured foods like yogurt. Probiotics live in the gut naturally and prebiotic-like substances are found in large quantities in breast milk.

Synbiotics are being added to formula in an effort to positively influence the type of intestinal flora or “bacteria in the gut”.  We hypothesize that this type of formula will make the intestinal flora similar to the intestinal flora of breastfed infants.

What synbiotic is being used in this study?

The synbiotic used in this study is Bifidobacterium lactis combined with galacto-oligosaccharride.  In full-term infants, breastfeeding induces the development of Bifidobacterium in the gut and remains the dominant organism in the gastrointestinal tract of the infant until weaning.  When added to infant formula, synbiotics may provide some of the same health benefits that are provided by the consumption of human milk.