Title
Beneficial Bacteria Treatment for Autism
Treating Gastrointestinal Problems in Children With Autism Using Beneficial Bacteria Treatment (BBT)
Phase
Phase 1/Phase 2Lead Sponsor
Arizona State UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Gastrointestinal Problems Autism Spectrum DisordersIntervention/Treatment
vancomycin human fecal microbiota omeprazole polyethylene glycol ...Study Participants
18This 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.
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.
an antibiotic
a bowel cleanse
a stomach acid suppressan
human fecal material; processed, frozen, administered orally
human fecal material; processed, frozen; administered orally and rectally
This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
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
| Event Type | Organ System | Event Term | All Groups |
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The GSRS is a measure of gastrointestinal symptoms. It includes 15 questions, rated on a Likert scale of 1-7, from no symptoms to severe symptoms, respectively (i.e., higher is worse). We report an average score for all 15 questions, so the possible range for the average score is also 1-7.
The PGI-R is a rating of change of 18 autism symptoms compared to baseline, with each symptom rated on a Likert scale from -3 (much worse) to zero (no change) to +3 (much better). We report the average change of the 18 symptoms, so the possible range is from -3 to +3.
Number of participants who had a clinically significant change in their blood safety markers (comprehensive metabolic panel including kidney/liver function and complete blood count with differential)
The CARS is an assessment of 15 autism-related symptoms. Each item is scored on a scale of 1 (no symptoms) to 4 (severe symptoms), and the scores for each symptom are summed to obtain a total score. So, the possible scores range from 15 to 60, with a higher score indicating greater severity.
The SRS is an assessment of social skills based on 65 items, where each item is scored on a range of 0 (no symptoms) to 3 (severe symptoms). The total score is a sum of the individual scores, so the total possible range is from 0 to 195, with a higher score indicating greater severity of symptoms.
The Short Sensory Profile is an assessment of sensory problems. However, the data on this scale was not collected due to administrative error.
The VABS is an assessment of adaptive behaviors, and we analyzed it to determine the developmental age of the participants, with possible scores ranging from 0 years to 21 years.
The DSR is a record of the type of stool that a participant had each day, using the Bristol Stool Form which ranges from 1 (very hard) to 7 (liquid). We then analyzed the data as % days of abnormal stools over a 14 day period, where an abnormal stool is defined as an unusually hard stool (types 1-2), unusually soft stool (types 6-7), or no stool that day. So, the possible range of % days of abnormal stools is from 0% to 100%, with a higher score indicating a more severe problem.
