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Beneficial Bacteria Treatment for Autism (BBT)

Primary Purpose

Gastrointestinal Problems, Autism Spectrum Disorders

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
oral Vancomycin
MoviPrep
Prilosec
human fecal material; processed, frozen administered orally
human fecal material; processed, frozen; administered orally and rectally
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Problems focused on measuring children

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Oral Group

    Rectal Group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Gastrointestinal Symptom Responsiveness Scale (GSRS)
    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 Outcome Measures

    Parent Global Impressions-Revised (PGI-R)
    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.
    Blood Safety Markers (Assessment of Blood Chemistry Panel and Complete Blood Count)
    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)
    Childhood Autism Rating Scale (CARS)
    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.
    Social Responsiveness Scale (SRS)
    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.
    Short Sensory Profile
    The Short Sensory Profile is an assessment of sensory problems. However, the data on this scale was not collected due to administrative error.
    Vineland Adaptive Behavior Scale (VABS)
    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.
    Daily Stool Record (DSR)
    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.

    Full Information

    First Posted
    March 30, 2015
    Last Updated
    November 27, 2019
    Sponsor
    Arizona State University
    Collaborators
    Northern Arizona University, University of Arizona, University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02504554
    Brief Title
    Beneficial Bacteria Treatment for Autism
    Acronym
    BBT
    Official Title
    Treating Gastrointestinal Problems in Children With Autism Using Beneficial Bacteria Treatment (BBT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Arizona State University
    Collaborators
    Northern Arizona University, University of Arizona, University of Minnesota

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastrointestinal Problems, Autism Spectrum Disorders
    Keywords
    children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral Group
    Arm Type
    Experimental
    Arm Description
    This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
    Arm Title
    Rectal Group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    oral Vancomycin
    Intervention Description
    an antibiotic
    Intervention Type
    Drug
    Intervention Name(s)
    MoviPrep
    Intervention Description
    a bowel cleanse
    Intervention Type
    Drug
    Intervention Name(s)
    Prilosec
    Intervention Description
    a stomach acid suppressan
    Intervention Type
    Biological
    Intervention Name(s)
    human fecal material; processed, frozen administered orally
    Intervention Description
    human fecal material; processed, frozen, administered orally
    Intervention Type
    Biological
    Intervention Name(s)
    human fecal material; processed, frozen; administered orally and rectally
    Intervention Description
    human fecal material; processed, frozen; administered orally and rectally
    Primary Outcome Measure Information:
    Title
    Gastrointestinal Symptom Responsiveness Scale (GSRS)
    Description
    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.
    Time Frame
    Baseline and 10 weeks (end of treatment)
    Secondary Outcome Measure Information:
    Title
    Parent Global Impressions-Revised (PGI-R)
    Description
    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.
    Time Frame
    Baseline and 10 weeks (end of treatment)
    Title
    Blood Safety Markers (Assessment of Blood Chemistry Panel and Complete Blood Count)
    Description
    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)
    Time Frame
    Baseline and 10 weeks (end of treatment)
    Title
    Childhood Autism Rating Scale (CARS)
    Description
    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.
    Time Frame
    Baseline and 10 weeks (end of treatment)
    Title
    Social Responsiveness Scale (SRS)
    Description
    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.
    Time Frame
    Baseline and 10 weeks (end of treatment)
    Title
    Short Sensory Profile
    Description
    The Short Sensory Profile is an assessment of sensory problems. However, the data on this scale was not collected due to administrative error.
    Time Frame
    baseline and 10 weeks
    Title
    Vineland Adaptive Behavior Scale (VABS)
    Description
    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.
    Time Frame
    baseline and 18 weeks (8 weeks after treatment stopped)
    Title
    Daily Stool Record (DSR)
    Description
    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.
    Time Frame
    Baseline and 10 weeks (end of treatment)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James B Adams, PhD
    Organizational Affiliation
    Arizona State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28122648
    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.
    Results Reference
    result

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