In this trial, investigators are looking at how Microbiota Transfer Therapy (MTT) helps treat children with gastrointestinal problems (constipation and/or diarrhea) who have Autism Spectrum Disorder (ASD). The therapy involves 10 days of an antibiotic called vancomycin, a bowel cleanse, and then 12 weeks of Fecal Microbiota (FM).
Investigators will study 70 participants to monitor the safety, tolerability, and efficacy of MTT in three parts. The first part is a randomized trial wherein subjects will get a 2 week treatment of either the oral vancomycin or a placebo, followed by Miralax to cleanse the bowels and oral administration of either FM or a placebo. In the second part, there will be an extension group which will be observed for 12 weeks and a treatment arm which will receive the same treatment as the first part except without vancomycin. The third part of the trial will be an evaluation at 6, 12, and 18 month intervals after treatment to see if the treatment is safe and effective over the long term.
- Child aged 5-17 years
- 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).
- GI disorder as defined below that has lasted for at least 3 years.
- No changes in medications, supplements, diet, therapies, or education in the last 3 months, and no intention to change them during the clinical trial.
- General good physical health aside from gastrointestinal problems
- Ability to swallow pills (without chewing)
- Antibiotics in last 3 months (does not apply to topical antibiotics)
- Probiotics in last 2 months, or fecal transplant in last 12 months
- Single-gene disorder (Fragile X, etc.)
- Major brain malformation
- Tube feeding
- Severe gastrointestinal problems that require immediate treatment (life-threatening)
- Ulcerative Colitis, Crohn’s Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions
- Severely underweight/malnourished (per physician clinical judgement)
- 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)
- Recent or scheduled surgeries
- Current participation in other clinical trials
- Females who are pregnant or who are sexually active without effective birth control.
- Allergy or intolerance to vancomycin or Miralax
- Clinically significant abnormalities at baseline on two blood safety tests: Comprehensive Metabolic Panel and Complete Blood Count with Differential.
- Psychotropic medication daily use – Current or within past 2 months – which are known to interfere in gastrointestinal function
- 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.
Arizona State University
Tempe, Arizona, United States, 85287Contact: James B Adams, PhD 480-965-3316 email@example.com
Arizona State University
Arizona State University Foundation
University of Minnesota
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