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NCT04114357 · ClinicalTrials.gov registry record · Phase 1
Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
A Phase 1 study of Type 1 Diabetes, sponsored by Indiana University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04114357 is a Phase 1 study of Type 1 Diabetes that has completed, run by Indiana University. The registered enrollment target is 12 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04114357, a Phase 1 study of Type 1 Diabetes, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Acetylated and Butyrylated High Amylose Maize Starch
Study Locations (1)
Indiana
- Indiana University School of Medicine - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-06-22 |
| Est. Completion | 2023-06-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04114357
The ClinicalTrials.gov registry entry for NCT04114357 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (99% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Acetylated and Butyrylated High Amylose Maize Starch is the first listed.
NCT04114357 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT04114357 about?
NCT04114357 is a clinical study titled "Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function". 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 pr...
What is the current status of trial NCT04114357?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-06-22. Estimated completion is 2023-06-09.
What conditions does trial NCT04114357 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT04114357?
The interventions under investigation include: Acetylated and Butyrylated High Amylose Maize Starch (DRUG).
Who is sponsoring clinical trial NCT04114357?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04114357 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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