Trial · NCT03408886
Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders
NCT03408886, Phase 2, Active not recruiting, Arizona State University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders. Trials, record NCT03408886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03408886
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders
- NCT number
- NCT03408886
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- Arizona State University
- Conditions
- Autism Spectrum Disorder, Gastrointestinal Disorder
- Interventions
- Vancomycin, MoviPrep, Full Spectrum Microbiota
- First posted
- 2018-01-24
- Last updated
- 2023-01-09
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Childhood Autism Rating Scale (CARS) from baseline to 10 weeks | baseline; month 2.5, 4.5, 10.5, 16.5, 22.5 | An evaluation by a trained evaluator of autism symptoms. The range is 15-60, and scores in the range of 27-30 or higher are indicative of autism. |
| Secondary | Change in Daily Stool Log (DSL) from baseline to 10 weeks | baseline for 2 weeks; daily for 18 weeks, and 2 weeks at month 10, 16, 22 | The DSL is a report of the number and type of stools over 14 days. Each stool is rated on a scale of 1-7, where 1=very hard, 4=normal, 7=very soft/liquid. The DSL is scored by the number of days of an abnormal stool (type 1-2 or 6-7) or no stool. |
| Secondary | Change in Social Responsiveness Scale - 2 from baseline to 10 weeks of treatment | baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18; months 10.5, 16.5, 22.5 | A questionnaire about social skills, where higher scores suggest more severe autism. Scores range from 0 to 195, with higher scores indicating more severe problems. |
| Secondary | Change in Aberrant Behavior Checklist from baseline to 10 weeks | baseline; month 2.5, 4.5, 10.5, 16.5, 22.5 | a questionnaire about aberrant behaviors. Scores range from 0 to 174, with higher scores indicating more severe behaviors |
| Other | Change in Gastrointestinal Stool and Symptom Questionnaire for Autism, from baseline to 10 weeks | baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18; month 10.5, 16.5, 22.5 | a questionnaire about GI-related symptoms. |
| Other | Change in Microbiome composition from baseline to 10 weeks | baseline; month 1, 2.5, 3.5, 4.5, 10.5, 16.5, 22.5 | analysis of the bacterial composition of stool samples, at the species, genus, and phylum level |
| Other | Change in the Vineland Adaptive Behavior Scale - II, from baseline to 10 weeks | baseline; month 2.5, 4.5, 22.5 | questionnaire about adaptive behaviors; it yields the developmental age of the participant |
| Other | Change in Ohio State University Clinical Impressions Scale, from baseline 10 weeks | baseline; month 2.5, 4.5 | assessment of autism symptoms by a clinician. It rates 10 symptoms on a scale of 1-7, with higher scores indicating worse symptoms. |
| Other | Change in Parent Global Impressions, from baseline to 10 weeks | baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18; month 10.5, 16.5, 22.5 | Assessment of autism symptoms. It rates 20 symptoms on a scale of 1-7, with higher scores indicating worse symptoms |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28122648 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03408886
GET https://conductscience.org/api/trials/v1/NCT03408886/registered