Phase 2
N=18
Beneficial Bacteria Treatment for Autism
Gastrointestinal Problems · Autism Spectrum Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02504554 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Gastrointestinal Symptom Responsiveness Scale (GSRS) — 2.74; 1.31 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- oral Vancomycin (Drug); MoviPrep (Drug); Prilosec (Drug); human fecal material; processed, frozen administered orally (Biological); human fecal material; processed, frozen; administered orally and rectally (Biological)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Arizona State University
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gastrointestinal Symptom Responsiveness Scale (GSRS) |
2.74; 1.31 | <0.001 sig |
| SECONDARY Parent Global Impressions-Revised (PGI-R) |
1.4 | <0.001 sig |
| SECONDARY Blood Safety Markers (Assessment of Blood Chemistry Panel and Complete Blood Count) |
— | — |
| SECONDARY Childhood Autism Rating Scale (CARS) |
39.7; 34.1 | <0.001 sig |
| SECONDARY Social Responsiveness Scale (SRS) |
116.2; 97.8 | <0.001 sig |
| SECONDARY Short Sensory Profile |
— | — |
| SECONDARY Vineland Adaptive Behavior Scale (VABS) |
5.39; 6.84 | <0.001 sig |
| SECONDARY Daily Stool Record (DSR) |
62; 34 | 0.002 sig |
Summary
This is an open-label clinical trial to investigate a combination therapy for treating gastrointestinal problems in children with autism spectrum disorders.
The combination therapy includes beneficial bacteria.
Eligibility Criteria
Inclusion Criteria
- Children ages 7-17 years
- Diagnosis of autism per Autism Diagnostic Interview-Revised (ADI-R)
- Moderate or Severe GI problems ( on the GSRS, a single score of 4 (severe) on any item, or a score of 3 (moderate) on two items, or a score of 2 (mild) or more on any 4 items
- No changes in medications, supplements, diet, therapies, or education in last 3 months, and no intention to change them during clinical trial
- General good physical health aside from gastrointestinal problems
- Cognitive Ability to Provide Informed Assent
Exclusion Criteria
- Antibiotics in last 6 months
- Probiotics in last 3 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
- Recent or scheduled surgeries
- Current participation in other clinical trials
Data sourced from ClinicalTrials.gov (NCT02504554). 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.