Evaluating the Effect of Prebiotics on the Gut Microbiome Profile and ß-cell Function in Newly-Diagnosed Type 1 Diabetes
DO YOU HAVE A CHILD WITH TYPE 1 DIABETES?
Researchers at Indiana University are studying prebiotics to see if they can help improve insulin production for children who have Type 1 Diabetes (T1D).
What is the difference between Prebiotics and Probiotics?
Probiotics are good bacteria like the ones found in your gut that help keep it healthy.
- Probiotics are found in foods like yogurt.
Prebiotics are what the good bacteria in your gut use as food.
- Prebiotics can be found in food and supplements that have dietary fibers.
Your child's participation in this study can help researchers determine whether using a prebiotic favorably affects insulin production and the balance of bacteria normally living in the intestine.
What is Involved?
Study participation includes 5 in-person study visits over the course of 12-16 weeks:
1. Study Visit #1
A screening visit to include: stool and blood collection, urine pregnancy test for female participants (to be repeated at each study visit), and questions regarding diet.
2. Study Visit #2
A diet questionnaire, stool collection, blood tests, placement of continuous glucose monitor (CGM) to be worn for 4 weeks, and placement into one of two groups: to receive the twice daily prebiotic for the first 4 weeks or second 4 weeks.
3. Study Visit #3
A diet questionnaire, stool collection, and blood tests. Researchers will review data from the CGM and will have participants complete a mixed meal tolerance test (MMTT) in which the participant will consume a nutritional supplement drink called 'Boost' and have blood drawn up to 7 times within 2 hours. Participants will switch groups at this time, taking the prebiotic for 4 weeks if they had not, or stopping the prebiotic at this point.
4. Study Visit #4
A diet questionnaire, stool collection, blood tests, and review of data from the CGM.
5. Study Visit #5
A diet questionnaire, stool collection, blood tests, review of data from the CGM, and MMTT.
Who is eligible to participate?
- Individuals 12-16 years of age
- Diagnosed with Type 1 Diabetes in the past 4-24 months
Participants will be compensated for their time and participation.
- Participants will receive a $50 gift card for each completed visit, for a total of up to $250. In addition, parking will be paid for at each study visit. You will be reimbursed for mileage if your round trip is at least 30 miles roundtrip to the clinic at a rate of $0.17/mile.
- Study visits will take place at Riley Children's Hospital in Indianapolis, IN
- Study participation lasts 12-16 weeks
- IRB Number: 1907172784
- Research Study Identifier: TX10798
- Principal Investigator: Heba Ismail
Contact the research team to learn more about this study.
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