Trial · NCT06503978
Microbiota Transplant Therapy for Children With Both Autism Spectrum Disorder and Gastrointestinal Disorders
NCT06503978, Phase 2, Unknown, Gut-Brain-Axis Therapeutics Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Microbiota Transplant Therapy for Children With Both Autism Spectrum Disorder and Gastrointestinal Disorders. Trials, record NCT06503978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06503978
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Microbiota Transplant Therapy for Children With Both Autism Spectrum Disorder and Gastrointestinal Disorders
- NCT number
- NCT06503978
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Gut-Brain-Axis Therapeutics Inc.
- Conditions
- Autism Spectrum Disorder, Gastro-Intestinal Disorder, Constipation, Diarrhea
- Interventions
- MTP-101P, Vancomycin, Miralax, Antacid, Placebo MTP-101P, Placebo Vancomycin
- First posted
- 2024-07-16
- Last updated
- 2024-09-25
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Childhood Autism Rating Scale (CARS-2) | Baseline (0-30 days prior to treatment) vs End of Treatment (Day 104) | A 15-item scale that can be used to both diagnose autism and ASD and to assess the overall severity of symptoms |
| Primary | Daily Stool Record (DSR) | Screening (0-120 days prior to Baseline) vs Baseline (0-30 days prior to treatment) vs End of Treatment (Day 104) | Participants will report the number of abnormal events during a 14 day period. An event includes no bowel movement during 1 day, unusually hard stool (Bristol Stool Form type 1-2), unusually soft stool (Bristol Stool Form type 6-7), four or more bowel movements in 1 day, abdominal pain, or use of GI medication. The units are number of events regardless of type of event. |
| Secondary | Gastrointestinal Symptom Rating Scale (GSRS) | Baseline (0-30 days prior to treatment) VS Day 14, 28,56,84 and 104 | An assessment of GI symptoms based on 15 questions, which are then scored in five domains (abdominal pain, reflux, indigestion, diarrhea, and constipation). Symptoms are rated on a 7-point Likert scale including no discomfort at all (1), slight discomfort (2), mild discomfort (3), moderate discomfort (4), moderately severe discomfort (5), severe discomfort (6), and very severe discomfort (7). |
| Secondary | Clinical Global Impression - Gastrointestinal (CGI-GI) | Baseline (0-30 days prior to treatment) VS End of Treatment (Day 104) | This assessment is conducted by the study physician and assess the severity of GI symptoms on a 7-point scale. The severity scale rates the severity of the patient's illness including normal, not at all ill (1), borderline mentally ill (2), mildly ill (3), moderately ill (4), markedly ill (5), severely ill (6), among the most extremely ill patients (7). |
| Secondary | Clinical Global Impression - Autism (CGI-A) | Baseline (0-30 days prior to treatment) VS End of Treatment (Day 104) | This assessment is conducted by the study physician and assess the severity of Autism Symptoms on a 7-point scale. The severity scale rates the severity of the patient's illness including normal, not at all ill (1), borderline mentally ill (2), mildly ill (3), moderately ill (4), markedly ill (5), severely ill (6), among the most extremely ill patients (7). |
| Secondary | National Survey on treatment Effectiveness for Autism (NSTEA) | End of Treatment (Day 104) | Assess the effectiveness of MTT on overall benefit (no benefit (0)/slight benefit(1)/moderate benefit (2)/good benefit (3)/great benefit (4)). |
| Secondary | Social Responsiveness Scale (SRS 2) | Baseline (0-30 days prior to treatment) VS End of Treatment (Day 104) | 65-item scale that assesses social impairments, a core issue in autism, including social awareness, social information processing, capacity for reciprocal social communication, social anxiety/avoidance, and autistic preoccupations and traits. |
| Secondary | Aberrant Behaviour Checklist (ABC-2) | Baseline (0-30 days prior to treatment) VS End of Treatment (Day 104) | assesses problem behaviors in five areas common in individuals with ASD, including irritability, social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech. |
| Secondary | CAAAS (subscale on GI symptoms) | Baseline (0-30 days prior to treatment) VS Day 14, 28,56,84 and 104 | This tool assesses both core ASD symptoms and a comprehensive list of common co-occurring symptoms in ASD, including gastrointestinal, behavioral, mental health, and physical health symptoms. 9-point severity scale from "none" to "major". There is also a "change" |
| Secondary | Comprehensive Assessment of Autism and Associated Symptoms (CAAAS) | Baseline (0-30 days prior to treatment) VS Day 14, 28,56,84 and 104 | This tool assesses both core ASD symptoms and a comprehensive list of common co-occurring symptoms in ASD, including gastrointestinal, behavioral, mental health, and physical health symptoms. 9-point severity scale from "none" to "major". There is also a "change" |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06503978
GET https://conductscience.org/api/trials/v1/NCT06503978/registered