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Prebiotic

Acetylated and Butyrylated High Amylose Maize Starch for Type 1 Diabetes

Phase 3

Waitlist Available

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 12 weeks

Awards & highlights

Study Summary

This trial will test whether a prebiotic called HAMS-AB can help prevent type 1 diabetes by improving the gut microbiome and glycemia in humans.

Eligible Conditions

Type 1 Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the gut microbiome profile

Secondary outcome measures

Changes in Beta cell Health.

Changes in Glycemia.

Changes in the Short Chain Fatty Acid Levels in the Gut.

Other outcome measures

Changes in frequency of Mucosal Associated invariant T (MAIT) cells

Changes in function of Mucosal Associated invariant T (MAIT) cells

Changes in phenotype of Mucosal Associated invariant T (MAIT) cells

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

This arm will consume the supplement daily for 4 weeks.

Group II: Control GroupActive Control1 Intervention

This arm will not receive the supplement for 4 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetylated and Butyrylated High Amylose Maize Starch

2020

Completed Phase 3

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

984 Previous Clinical Trials

1,080,332 Total Patients Enrolled

National Center for Advancing Translational Sciences (NCATS)NIH

322 Previous Clinical Trials

401,512 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will people who are more than 50 years old be able to participate in this research project?

"According to the age requirements set out by the trial's inclusion criteria, potential participants must be betwen 11 and 17."

Answered by AI

Is there any danger to consumers associated with Acetylated and Butyrylated High Amylose Maize Starch?

"Acetylated and Butyrylated High Amylose Maize Starch is being trialed in Phase 3, meaning that while there is data supporting efficacy, there is also multiple rounds of data supporting safety. Our team has estimated the safety to be a 3 on a scale from 1 to 3."

Answered by AI

To whom does this experiment offer the chance for inclusion?

"This trial is looking for 12 child participants, aged 11-17, who currently have diabetes and autoimmune diseases. Additionally, it is important that potential participants meet the following requirements: Be willing to use contraception if sexually active, have a BMI lower than 85% for their age and sex, test positive for any of the diabetes-related autoantibodies [insulin autoantibody (if tested within 14 days of diagnosis), glutamic acid decarboxylase (GAD), insulinoma-associated protein-2 (IA-2), or Zinc transporter 8 autoantibodies (ZnT8)], be willing"

Answered by AI

Are there any other notable scientific papers that mention Acetylated and Butyrylated High Amylose Maize Starch?

"There are currently 8 Acetylated and Butyrylated High Amylose Maize Starch clinical trials underway. Out of these 8, 2 have progressed to Phase 3 testing. Most of the Chapel Hill, North carolina based trials are for this treatment, but there are a total of 14 facilities running these types of trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Heba M. Ismail 2020. "Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04114357.