Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
Study NCT ID:
NCT04114357
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2019-09-30
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
Evaluating the Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function in Newly Diagnosed Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| KL2TR002530 | NIH | None | https://reporter.nih.gov/quic… | View |
| UL1TR002529 | NIH | None | https://reporter.nih.gov/quic… | View |