MTT for Children With ASD Who Have Gastrointestinal Disorders
Autism Spectrum Disorder, Gastro-Intestinal Disorder, Constipation
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring fecal transplant, fecal microbiota transplant, intestinal microbiota transplant, microbiota transplant, autism, autism spectrum disorder
Eligibility Criteria
Inclusion Criteria for Children with ASD
- 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 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)
Exclusion Criteria for Children with ASD
- 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.
Sites / Locations
- Arizona State University
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Group A - Treatment Group
Group B - Control Group (Miralax only for 1 day)
This group will receive vancomycin for 14 days, then Miralax for 1 day, then intestinal microbiota for 2 days at high dose, then intestinal microbiota for 12 weeks at a maintenance dose
This group will receive placebo vancomycin for 14 days, then Miralax for 1 day, then placebo intestinal microbiota for 2 days at high dose, then placebo intestinal microbiota for 12 weeks at a maintenance dose