Evaluating the Effect of Prebiotics on the Gut Microbiome Profile and ß-cell Function in Newly-Diagnosed Type 1 Diabetes

Evaluating the Effect of Prebiotics on the Gut Microbiome Profile and ß-cell Function in Newly-Diagnosed Type 1 Diabetes

Overview

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.
 
 
 

Description

What is Involved?
Study participation includes 5 in-person study visits at Riley Children's Hospital in Indianapolis 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

Eligibility

You may be eligible for this study if you meet the following criteria:

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  • Age: Between 12 Years - 16 Years
  • Gender: Male or Female

Eligibility Criteria:
  • Individuals 12-16 years of age
  • Diagnosed with Type 1 Diabetes in the past 4 to 24 months
 
Exclusion Criteria:
  • Individuals with severe, active diseases affecting diet or requiring chronic medication will not be eligible.
  • Individuals requiring the use of anti-psychotic medication will not be eligible.
  • Pregnant or breastfeeding women will not be eligible.
  • Individuals with celiac or gastrointestinal disease, immune compromise, or recurrent infection will not be eligible.

Additional Information:

Updated on 20 Nov 2022 . Study ID: TX10798

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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