Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2014-07-31
2016-04-30
Brief Summary
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The combination therapy includes beneficial bacteria.
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Detailed Description
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It involves a combination therapy including beneficial bacteria.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oral Group
This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
oral Vancomycin
an antibiotic
MoviPrep
a bowel cleanse
Prilosec
a stomach acid suppressan
human fecal material; processed, frozen administered orally
human fecal material; processed, frozen, administered orally
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.
oral Vancomycin
an antibiotic
MoviPrep
a bowel cleanse
Prilosec
a stomach acid suppressan
human fecal material; processed, frozen; administered orally and rectally
human fecal material; processed, frozen; administered orally and rectally
Interventions
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oral Vancomycin
an antibiotic
MoviPrep
a bowel cleanse
Prilosec
a stomach acid suppressan
human fecal material; processed, frozen administered orally
human fecal material; processed, frozen, administered orally
human fecal material; processed, frozen; administered orally and rectally
human fecal material; processed, frozen; administered orally and rectally
Eligibility Criteria
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Inclusion Criteria
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
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
7 Years
17 Years
ALL
No
Sponsors
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Northern Arizona University
OTHER
University of Arizona
OTHER
University of Minnesota
OTHER
Arizona State University
OTHER
Responsible Party
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Principal Investigators
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James B Adams, PhD
Role: PRINCIPAL_INVESTIGATOR
Arizona State University
References
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Kang DW, Adams JB, Vargason T, Santiago M, Hahn J, Krajmalnik-Brown R. Distinct Fecal and Plasma Metabolites in Children with Autism Spectrum Disorders and Their Modulation after Microbiota Transfer Therapy. mSphere. 2020 Oct 21;5(5):e00314-20. doi: 10.1128/mSphere.00314-20.
Kang DW, Adams JB, Coleman DM, Pollard EL, Maldonado J, McDonough-Means S, Caporaso JG, Krajmalnik-Brown R. Long-term benefit of Microbiota Transfer Therapy on autism symptoms and gut microbiota. Sci Rep. 2019 Apr 9;9(1):5821. doi: 10.1038/s41598-019-42183-0.
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.
Other Identifiers
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STUDY00001053
Identifier Type: -
Identifier Source: org_study_id
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