CompletedPhase 1/2

Beneficial Bacteria Treatment for Autism

18 participantsStarted 2014-07

Plain-language 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.

Who can participate

Age range7 Years – 17 Years

SexALL

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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

What they're measuring

Gastrointestinal Symptom Responsiveness Scale (GSRS)

Timeframe: Baseline and 10 weeks (end of treatment)

Trial details

NCT IDNCT02504554

SponsorArizona State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-04

Results submitted2018-02-09

View on ClinicalTrials.gov More Gastrointestinal Problems trials