drugset / Trial / NCT04114357

Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function

NCT04114357 ↗

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

EvaluationDrugModalityDoseRoute
Subject Acetylated and Butyrylated High Amylose Maize Starch Other / unclassified — Oral