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Prebiotic
Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
Phase 1
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after completion of each 4 week sequence
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a special type of starch that helps good bacteria in the gut to grow and produce beneficial substances. It targets children and teens with newly diagnosed type 1 diabetes to see if it can improve their gut health and blood sugar control. The study will measure changes in gut bacteria, blood sugar levels, and cell health.
Eligible Conditions
- Type 1 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before and after completion of each 4 week sequence
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after completion of each 4 week sequence
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the Gut Microbiome Profile
Secondary study objectives
C-peptide Levels (Changes in Beta Cell Health).
Changes in Average Glucose
Changes in the Short Chain Fatty Acid Levels in the Gut.
Other study objectives
Changes in Frequency of Mucosal Associated Invariant T (MAIT) Cells
Changes in Function of Mucosal Associated Invariant T (MAIT) Cells
Changes in Phenotype of Mucosal Associated Invariant T (MAIT) Cells
Side effects data
From 2023 Phase 1 trial • 12 Patients • NCT0411435711%
Dental Pain
11%
cold
11%
flatulence
11%
yeast infection
11%
abdominal pain
11%
emesis
11%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intervention Group
Control Group
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Supplement Intervention and Control Diet, then Control Diet AloneExperimental Treatment1 Intervention
This group will first consume the supplement daily for 4 weeks in addition to the diabetic diet then cross-over to follow the diabetic diet for 4 weeks.
Group II: Control Diet Alone, then Supplement Intervention and Control DietActive Control1 Intervention
This group will follow the control diet for 4 weeks first then cross-over to receive the supplement for 4 weeks in addition to the diabetic diet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylated and Butyrylated High Amylose Maize Starch
2020
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,045 Previous Clinical Trials
1,316,872 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
377 Previous Clinical Trials
413,015 Total Patients Enrolled