drugset / Trial / NCT04114357
Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
Phase 1
Completed
12 enrolled
Indiana University
National Center for Advancing Translational Sciences (NCATS) · collab
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2020-06-22
- Primary completion
- 2023-06-09
- Completion
- 2023-06-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetylated and Butyrylated High Amylose Maize Starch | Other / unclassified | — | Oral |