Trials / Completed
CompletedNCT04114357
Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
Evaluating the Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function in Newly Diagnosed Type 1 Diabetes
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Indiana University · Academic / Other
- Sex
- All
- Age
- 11 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
Data suggest that intestinal microbiota might be critically involved both in autoimmunity and in glucose homeostasis. An acetylated and butyrylated form of high amylose maize starch (HAMS-AB) that increases beneficial short chain fatty acid (SCFA) production has been safe and effective in disease prevention in mouse type 1 diabetes (T1D) models. The objective of this application is to assess the effect of administering a prebiotic, such as HAMS- AB, on the gut microbiome profile, glycemia and β-cell function in humans with T1D.
Detailed description
This is a pilot, single center clinical trial to evaluate the effect of using the prebiotic, HAMS-AB, on the gut microbiome profile, glycemia and β-cell function in children and adolescents ages 12-16 years with recently diagnosed type 1 diabetes. Approximately 12 participants will be randomized to first to take the supplement and follow the diabetic diet or follow a diabetic diet alone for 4 weeks and then cross-over after a 4 week washout period. The primary objective is to determine the effect of using the prebiotic on the gut microbiome profile in youth with T1D. The secondary objectives are to determine the effect of using the prebiotic on SCFA production, glycemia and β-cell health and function. Exploratory outcomes include changes in MAIT cells.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acetylated and Butyrylated High Amylose Maize Starch | Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner for 4 weeks |
Timeline
- Start date
- 2020-06-22
- Primary completion
- 2023-06-09
- Completion
- 2023-06-09
- First posted
- 2019-10-03
- Last updated
- 2024-10-01
- Results posted
- 2024-09-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04114357. Inclusion in this directory is not an endorsement.