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ACTIVE NOT RECRUITING

NCT04182633

PHASE2

MTT for Children With ASD Who Have Gastrointestinal Disorders

Sponsor: Arizona State University

View on ClinicalTrials.gov

Summary

The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating children with Autism Spectrum Disorder (ASD) and gastrointestinal problems (primarily constipation and/or diarrhea). MTT involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by a bowel cleanse, followed by 12 weeks of Fecal Microbiota (FM).

Official title: Microbiota Transfer Therapy for Children With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders

Key Details

Gender

All

Age Range

5 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-11-15

Completion Date

2025-12-30

Last Updated

2025-04-25

Healthy Volunteers

Conditions

Autism Spectrum Disorder Gastro-Intestinal Disorder Constipation Diarrhea

Interventions

COMBINATION_PRODUCT

vancomycin, Miralax, intestinal microbiota

vancomycin for 14 days, then Miralax for 1 day, then intestinal microbiota (high dose for 2 days, then maintenance dose for 12 weeks)

COMBINATION_PRODUCT

placebo vancomycin, Miralax, placebo intestinal microbiota

placebo vancomycin for 14 days, then Miralax for 1 day, then placebo intestinal microbiota (high dose for 2 days, then maintenance dose for 12 weeks)

Inclusion Criteria for Children with ASD 1. Child aged 5-17 years 2. Diagnosis of autism per the Childhood Autism Rating Scale 2 (CARS-2) and either the Autism Diagnostic Interview-Revised (ADI-R) or the Autism Diagnostic Observation Schedule 2 (ADOS 2). 3. GI disorder as defined below that has lasted for at least 3 years. 4. No changes in medications, supplements, diet, therapies, or education in last 3 months, and no intention to change them during the clinical trial. 5. General good physical health aside from gastrointestinal problems 6. Ability to swallow pills (without chewing) Exclusion Criteria for Children with ASD 1. Antibiotics in last 3 months (does not apply to topical antibiotics) 2. Probiotics in last 2 months, or fecal transplant in last 12 months 3. Single-gene disorder (Fragile X, etc.) 4. Major brain malformation 5. Tube feeding 6. Severe gastrointestinal problems that require immediate treatment (life-threatening) 7. Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions 8. Severely underweight/malnourished (per physician clinical judgement) 9. Unstable, poor health; seizure disorder that is not responsive to treatment or not on stable management or complex type; or other health conditions that would significantly increase their risk of adverse effects (per physician clinical judgement) 10. Recent or scheduled surgeries 11. Current participation in other clinical trials 12. Females who are pregnant or who are sexually active without effective birth control. 13. Allergy or intolerance to vancomycin or Miralax 14. Clinically significant abnormalities at baseline on two blood safety tests: Comprehensive Metabolic Panel and Complete Blood Count with Differential. 15. Psychotropic medication daily use - Current or within past 2 months - which are known to interfere in gastrointestinal function 16. Evidence of significant impairment of immune system, or taking medications that can compromise the immune system, and thus increase risk if exposed to multiple-drug resistant bacteria.

Locations (1)

Arizona State University

Tempe, Arizona, United States