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Completed

NCT Number: NCT02504554

Beneficial Bacteria Treatment for Autism

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.

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Key information

Conditions

Gastrointestinal Problems Autism Spectrum Disorder Autism Spectrum Disorders Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Vancomycin

Drug

an antibiotic

MoviPrep

Drug

a bowel cleanse

Prilosec

Drug

a stomach acid suppressan

human fecal material; processed, frozen administered orally

Biological

human fecal material; processed, frozen, administered orally

human fecal material; processed, frozen; administered orally and rectally

Biological

human fecal material; processed, frozen; administered orally and rectally

Primary outcomes

  1. Gastrointestinal Symptom Responsiveness Scale (GSRS)

    Time frame: Baseline and 10 weeks (end of treatment)

    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.

Secondary outcomes

  1. Parent Global Impressions-Revised (PGI-R)

    Time frame: Baseline and 10 weeks (end of treatment)

    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.

  2. Blood Safety Markers (Assessment of Blood Chemistry Panel and Complete Blood Count)

    Time frame: Baseline and 10 weeks (end of treatment)

    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)

  3. Childhood Autism Rating Scale (CARS)

    Time frame: Baseline and 10 weeks (end of treatment)

    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.

  4. Social Responsiveness Scale (SRS)

    Time frame: Baseline and 10 weeks (end of treatment)

    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.

  5. Short Sensory Profile

    Time frame: baseline and 10 weeks

    The Short Sensory Profile is an assessment of sensory problems.

    However, the data on this scale was not collected due to administrative error.

  6. Vineland Adaptive Behavior Scale (VABS)

    Time frame: baseline and 18 weeks (8 weeks after treatment stopped)

    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.

  7. Daily Stool Record (DSR)

    Time frame: Baseline and 10 weeks (end of treatment)

    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.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Northern Arizona University
  • University of Arizona
  • University of Minnesota

Registry information

Official study title

Treating Gastrointestinal Problems in Children With Autism Using Beneficial Bacteria Treatment (BBT)

Acronym: BBT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2015
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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