Phase 1
N=12
Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04114357 ↗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
| Outcome | Result | p-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
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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.