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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: Completed Phase 1 study of Type 1 Diabetes, sponsored by Indiana University.
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 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
We planned to assess the effect of administering acetylated and butyrylated high amylose maize starch (HAMS-AB) on the gut microbiome profile in people with recently-diagnosed type 1 diabetes (T1D) by sequencing the gut microbiome profile. This measure was assesed using the absolute abundance of certain bacterial species of interest. The changes will be compared before and after each 4 week time period.
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 |
What the finished NCT04114357 record still lists
NCT04114357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04114357's enrollment target sits among peer trials
12 176th of 198 higher than 19 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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