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

Type 1 Diabetes Clinical Trial

Official title: Evaluating the Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function in Newly Diagnosed Type 1 Diabetes

Status Completed

Clinical Trial 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.

Clinical Trial 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 first to take the supplement or follow a diabetic diet 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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

• NCT number: NCT04114357
• Study type: Interventional
• Source: Indiana University
• Status: Completed
• Phase: Phase 3
• Start date: June 22, 2020
• Completion date: June 9, 2023