Mode
Text Size
Log in / Sign up
Phase 1 N=12 Randomized Treatment

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

Type 1 Diabetes

Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Change in the Gut Microbiome Profile — 818.5; 229; 1610; 177 species count

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Acetylated and Butyrylated High Amylose Maize Starch (Drug)
Age
Pediatric · 11+ yrs
Sex
All
Sponsor
Indiana University
Primary completion
Jun 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in the Gut Microbiome Profile
818.5; 229; 1610; 177; 4964; 2632
SECONDARY
Changes in the Short Chain Fatty Acid Levels in the Gut.
23; 19; 16; 16; 60; 56
SECONDARY
Changes in Average Glucose
256; 228; 232; 217
SECONDARY
C-peptide Levels (Changes in Beta Cell Health).
2.0; 1.7; 2.7; 2.6

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.

Eligibility Criteria

Inclusion Criteria

  • Be between 11-17 years of age
  • Willing to consume HAMS-AB and follow a diabetic diet
  • Diagnosed by American Diabetes Association criteria with T1D in the last 4-36 months
  • Random non-fasting C-peptide of 0.17nmol/ml or greater
  • Willing to use an effective form of contraception if sexually active
  • BMI< 85% for age and sex
  • Positive for any one of the following diabetes-related autoantibodies that are tested clinically [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)].

Exclusion Criteria

  • Presence of severe, active disease that interferes with dietary intake or requires the use of chronic medication, except for well-controlled hypothyroidism and mild asthma not requiring oral steroids.
  • Diabetes other than T1D (Known monogenic forms of diabetes, Type 2 diabetes)
  • Chronic illness known to affect glucose metabolism (e.g. Cushing syndrome, polycystic ovarian disorder, cystic fibrosis) or taking medications that affect glucose metabolism (e.g. steroids, metformin)
  • Psychiatric impairment or current use of anti-psychotic medication
  • Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.
  • Female participants of child-bearing age with reproductive potential, must not be pregnant and agree to use an effective form of birth control or be abstinent during the study period (see below)
  • History of recurrent infections
  • History of on-going infections or antibiotic treatment within the past three months
  • History of immune compromise
  • Steroid intake (inhaled or oral)
  • Other immunosuppressant use in past 6 months
  • History of gastrointestinal disease
  • Possible or confirmed celiac disease
  • Pregnancy or possible pregnancy
  • Allergy to corn (prebiotic)
  • Allergy to milk or milk products or soy present in Boost
  • Participation in other intervention research trials within the past 3 months
  • Anticipate major changes in diabetes management during study (change from injection to pump, new start of continuous glucose monitoring)
  • Consuming high fiber or vegetarian diet (consuming three or more servings of high fiber foods on 4 or more days per week) using validated dietary assessments (see below under schedule of events table).
  • Taking fiber supplements

-

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04114357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search