CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Acetylated and Butyrylated High Amylose Maize Starchdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04114357
NCT04114357Phase 1Completed
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Evaluating the Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function in Newly Diagnosed Type 1 Diabetes

Indiana University·interventional·Posted Oct 3, 2019·Updated Oct 1, 2024

In Brief

A Phase 1 clinical trial evaluating Acetylated and Butyrylated High Amylose Maize Starch for Type 1 Diabetes. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States
CollaboratorsNational Center for Advancing Translational Sciences (NCATS)

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedOct 3, 2019
Enrollment StartJun 22, 2020
Primary CompletionJun 9, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.7 years ago

Interventions

Acetylated and Butyrylated High Amylose Maize Starchdrug

Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner for 4 weeks