Clinical trial NCT02504554: Beneficial Bacteria Treatment for Autism
Official title: Treating Gastrointestinal Problems in Children With Autism Using Beneficial Bacteria Treatment (BBT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gastrointestinal Problems
Autism Spectrum Disorders
Keywords: children
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Northern Arizona University
name: University of Arizona
name: University of Minnesota
First posted: 2015-07-22
Enrollment: 18
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is an open-label clinical trial to evaluate the safety, tolerability, and feasibility of a combination therapy to treat gastrointestinal problems in children with autism spectrum disorders.

It involves a combination therapy including beneficial bacteria.

Eligibility criteria: Inclusion Criteria:

1. Children ages 7-17 years
2. Diagnosis of autism per Autism Diagnostic Interview-Revised (ADI-R)
3. 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
4. No changes in medications, supplements, diet, therapies, or education in last 3 months, and no intention to change them during clinical trial
5. General good physical health aside from gastrointestinal problems
6. Cognitive Ability to Provide Informed Assent

Exclusion Criteria:

1. Antibiotics in last 6 months
2. Probiotics in last 3 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
9. Recent or scheduled surgeries
10. Current participation in other clinical trials

Primary outcomes:
measure: Gastrointestinal Symptom Responsiveness Scale (GSRS)
timeFrame: Baseline and 10 weeks (end of treatment)
Secondary outcomes:
measure: Parent Global Impressions-Revised (PGI-R)
timeFrame: Baseline and 10 weeks (end of treatment)
measure: Blood Safety Markers (Assessment of Blood Chemistry Panel and Complete Blood Count)
timeFrame: Baseline and 10 weeks (end of treatment)
measure: Childhood Autism Rating Scale (CARS)
timeFrame: Baseline and 10 weeks (end of treatment)
measure: Social Responsiveness Scale (SRS)
timeFrame: Baseline and 10 weeks (end of treatment)
measure: Short Sensory Profile
timeFrame: baseline and 10 weeks
measure: Vineland Adaptive Behavior Scale (VABS)
timeFrame: baseline and 18 weeks (8 weeks after treatment stopped)
measure: Daily Stool Record (DSR)
timeFrame: Baseline and 10 weeks (end of treatment)
Other outcomes:
Locations:
Study officials:
affiliation: Arizona State University
name: James B Adams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang DW, Adams JB, Gregory AC, Borody T, Chittick L, Fasano A, Khoruts A, Geis E, Maldonado J, McDonough-Means S, Pollard EL, Roux S, Sadowsky MJ, Lipson KS, Sullivan MB, Caporaso JG, Krajmalnik-Brown R. Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study. Microbiome. 2017 Jan 23;5(1):10. doi: 10.1186/s40168-016-0225-7.