Status:
COMPLETED
Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
11-17 years
Phase:
PHASE1
Brief 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 inc...
Detailed Description
This is a pilot, single center clinical trial to evaluate the effect of using the prebiotic, HAMS-AB, on the gut microbiome profile, glycemia and β-cell function in children and adolescents ages 12-16...
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04114357
Start Date
June 22 2020
End Date
June 9 2023
Last Update
October 1 2024
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202