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Prebiotic

Acetylated and Butyrylated High Amylose Maize Starch for Type 1 Diabetes

Phase 1

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 before and after completion of each 4 week sequence

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special type of starch that helps good bacteria in the gut to grow and produce beneficial substances. It targets children and teens with newly diagnosed type 1 diabetes to see if it can improve their gut health and blood sugar control. The study will measure changes in gut bacteria, blood sugar levels, and cell health.

Eligible Conditions

Type 1 Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after completion of each 4 week sequence

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after completion of each 4 week sequence

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after completion of each 4 week sequence for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the Gut Microbiome Profile

Secondary study objectives

C-peptide Levels (Changes in Beta Cell Health).

Changes in Average Glucose

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

Other study objectives

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

Side effects data

From 2023 Phase 1 trial • 12 Patients • NCT04114357

11%

abdominal pain

11%

Dental Pain

11%

Nausea

11%

cold

11%

flatulence

11%

yeast infection

11%

emesis

100%

80%

60%

40%

20%

Study treatment Arm

Intervention Group

Control Group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Supplement Intervention and Control Diet, then Control Diet AloneExperimental Treatment1 Intervention

This group will first consume the supplement daily for 4 weeks in addition to the diabetic diet then cross-over to follow the diabetic diet for 4 weeks.

Group II: Control Diet Alone, then Supplement Intervention and Control DietActive Control1 Intervention

This group will follow the control diet for 4 weeks first then cross-over to receive the supplement for 4 weeks in addition to the diabetic diet.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetylated and Butyrylated High Amylose Maize Starch

2020

Completed Phase 1

~20

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