Gastrointestinal ProblemsPhase 1/2BBTNCT02504554
Beneficial Bacteria Treatment for Autism
A Phase 1/2 study testing oral Vancomycin, MoviPrep and Prilosec in people with Gastrointestinal Problems and Autism Spectrum Disorders, run by Arizona State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Gastrointestinal Problems, Autism Spectrum Disorders
- What is being tested?
- oral Vancomycin, MoviPrep and Prilosec
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Apr 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
About this study
Official title: Treating Gastrointestinal Problems in Children With Autism Using Beneficial Bacteria Treatment (BBT)
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.
Read the 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.
- Being tested
- oral Vancomycin, MoviPrep, Prilosec, human fecal material; processed, frozen administered orally, human fecal material; processed, frozen; administered orally and rectally
- Keywords
- children
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral VancomycinDrug
an antibiotic
MoviPrepDrug
a bowel cleanse
PrilosecDrug
a stomach acid suppressan
human fecal material; processed, frozen administered orallyBiological
human fecal material; processed, frozen, administered orally
human fecal material; processed, frozen; administered orally and rectallyBiological
human fecal material; processed, frozen; administered orally and rectally
| Study group | Role | What they receive |
|---|---|---|
| Oral Group | Experimental | This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen. Receives: Drug: oral Vancomycin; Drug: MoviPrep; Drug: Prilosec; Biological: human fecal material; processed, frozen administered orally |
| Rectal Group | Experimental | 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. Receives: Drug: oral Vancomycin; Drug: MoviPrep; Drug: Prilosec; Biological: human fecal material; processed, frozen; administered orally and rectally |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 10 weeks (end of treatment)
Secondary outcomes (7)
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.
Measured: Baseline and 10 weeks (end of treatment)
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)
Measured: Baseline and 10 weeks (end of treatment)
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.
Measured: Baseline and 10 weeks (end of treatment)
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.
Measured: Baseline and 10 weeks (end of treatment)
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.
Measured: baseline and 10 weeks
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.
Measured: baseline and 18 weeks (8 weeks after treatment stopped)
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.
Measured: Baseline and 10 weeks (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJul 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal ProblemsStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Arizona University, University of Arizona, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- James B Adams, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504554
- Sponsor's protocol ID
- STUDY00001053
- Acronym
- BBT
- Status last verified
- Aug 2025
- First submitted
- 30 Mar 2015
- Last updated
- 12 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 33087514Kang 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.
PubMed 30967657Kang 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.
PubMed 28122648
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Gastrointestinal Problems in Children With Autism Using Beneficial Bacteria Treatment (BBT)
- ClinicalTrials.gov ID
- NCT02504554
- Acronym / sponsor ID
- BBT / STUDY00001053
- Keywords
- children
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Northern Arizona University, University of Arizona, University of Minnesota
- Study start
- Jul 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Posted 18 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Group | Experimental | Drug: oral Vancomycin, Drug: MoviPrep, Drug: Prilosec, Biological: human fecal material; processed, frozen administered orallyThis group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen. |
| Rectal Group | Experimental | Drug: oral Vancomycin, Drug: MoviPrep, Drug: Prilosec, Biological: human fecal material; processed, frozen; administered orally and rectallyThis group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- Antibiotics in last 6 months
- Probiotics in last 3 months
- Single-gene disorder (Fragile X, etc.)
- Major brain malformation
- Tube feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral Vancomycinan antibiotic | Drug | Oral Group, Rectal Group |
| MoviPrepa bowel cleanse | Drug | Oral Group, Rectal Group |
| Priloseca stomach acid suppressan | Drug | Oral Group, Rectal Group |
| human fecal material; processed, frozen administered orallyhuman fecal material; processed, frozen, administered orally | Biological | Oral Group |
| human fecal material; processed, frozen; administered orally and rectallyhuman fecal material; processed, frozen; administered orally and rectally | Biological | Rectal Group |
Primary outcome
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.
7 secondary outcomes
Parent Global Impressions-Revised (PGI-R)
Time frame: Baseline and 10 weeks (end of treatment)
Blood Safety Markers (Assessment of Blood Chemistry Panel and Complete Blood Count)
Time frame: Baseline and 10 weeks (end of treatment)
Childhood Autism Rating Scale (CARS)
Time frame: Baseline and 10 weeks (end of treatment)
Social Responsiveness Scale (SRS)
Time frame: Baseline and 10 weeks (end of treatment)
Short Sensory Profile
Time frame: baseline and 10 weeks
Vineland Adaptive Behavior Scale (VABS)
Time frame: baseline and 18 weeks (8 weeks after treatment stopped)
Daily Stool Record (DSR)
Time frame: Baseline and 10 weeks (end of treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33087514Kang 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.
- Results publication: PubMed 30967657Kang 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.
- Results publication: PubMed 28122648Kang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James B Adams, PhD principal investigator
Arizona State University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing oral Vancomycin, MoviPrep and Prilosec in people with Gastrointestinal Problems and Autism Spectrum Disorders, run by Arizona State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Symptom Responsiveness Scale (GSRS) (time frame: Baseline and 10 weeks (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02504554, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.