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faq

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?

How will the study protect our baby?

What will you do with the information gathered?

Why do you collect stool?

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?

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

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.

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.

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.