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Trial record 1 of 1 for:    nct02504554
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Beneficial Bacteria Treatment (BBT)

This study has been completed.
Sponsor:
Collaborators:
Northern Arizona University
University of Arizona
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Arizona State University
ClinicalTrials.gov Identifier:
NCT02504554
First received: March 30, 2015
Last updated: January 24, 2017
Last verified: January 2016
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Problems Autism Spectrum Disorders Drug: oral Vancomycin Drug: MoviPrep Drug: Prilosec Biological: human fecal material; processed, frozen administered orally Biological: human fecal material; processed, frozen; administered orally and rectally Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Treating Gastrointestinal Problems in Children With Autism Using Beneficial Bacteria Treatment (BBT)

Resource links provided by NLM:


Further study details as provided by Arizona State University:

Primary Outcome Measures:
  • Gastrointestinal Symptom Responsiveness Scale [ Time Frame: 10 weeks ]
    assessment of gastrointestinal symptoms


Secondary Outcome Measures:
  • Parent Global Impressions-Revised [ Time Frame: 10 weeks ]
    assessment of autism and related symptoms

  • blood safety markers (assessment of blood chemistry panel and complete blood count) [ Time Frame: 10 weeks ]
    assessment of blood chemistry panel and complete blood count

  • Childhood Autism Rating Scale [ Time Frame: 10 weeks ]
    assessment of autism symptoms

  • Social Responsiveness Scale [ Time Frame: 10 weeks ]
    assessment of social skills

  • Short Sensory Profile [ Time Frame: 10 weeks ]
    assessment of sensory sensitivity

  • Vineland Adaptive Behavior Scale [ Time Frame: 18 weeks ]
    assessment of development

  • stool diary [ Time Frame: 10 weeks ]
    assessment of constipation/diarrhea


Estimated Enrollment: 20
Study Start Date: July 2014
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Group
This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
Drug: oral Vancomycin
an antibiotic
Drug: MoviPrep
a bowel cleanse
Drug: Prilosec
a stomach acid suppressan
Biological: human fecal material; processed, frozen administered orally
human fecal material; processed, frozen, administered orally
Experimental: Rectal Group
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.
Drug: oral Vancomycin
an antibiotic
Drug: MoviPrep
a bowel cleanse
Drug: Prilosec
a stomach acid suppressan
Biological: human fecal material; processed, frozen; administered orally and rectally
human fecal material; processed, frozen; administered orally and rectally

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

Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02504554

Sponsors and Collaborators
Arizona State University
Northern Arizona University
University of Arizona
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: James B Adams, PhD Arizona State University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT02504554     History of Changes
Other Study ID Numbers: STUDY00001053
Study First Received: March 30, 2015
Last Updated: January 24, 2017

Keywords provided by Arizona State University:
children

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Omeprazole
Vancomycin
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 28, 2017