Trial · NCT06321796
Microbiota Transfer Therapy for Children and Adults With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders
NCT06321796, Phase 2, Unknown, Gut-Brain-Axis Therapeutics Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Microbiota Transfer Therapy for Children and Adults With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders. Trials, record NCT06321796. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06321796
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Microbiota Transfer Therapy for Children and Adults With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders
- NCT number
- NCT06321796
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Gut-Brain-Axis Therapeutics Inc.
- Conditions
- Pitt Hopkins Syndrome
- Interventions
- MTP-101P, Vancomycin, Magnesium Citrate, Antacid, Placebo MTP-101P, Placebo Vancomycin
- First posted
- 2024-03-20
- Last updated
- 2024-03-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Daily Stool Record (DSR) | Baseline (for 14 days pre-treatment) vs End of Treatment (Days 82-95 of treatment). | 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. |
| Primary | Safety Measures (Adverse Events) | Days 0 to 99 of treatment | Safety will be assessed based on the number of adverse events during treatment for each group (Group A and Group B). Units are number of adverse events. |
| Secondary | Gastrointestinal Symptom Rating Scale (GSRS) | Baseline (pre-treatment) vs End of Treatment (After 95 days of treatment) | 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 (pre-treatment) vs End of Treatment (After 99 days of treatment) | 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 - Pitt Hopkins (CGI-PTHS) | Baseline (pre-treatment) vs End of Treatment (After 99 days of treatment). | This assessment is conducted by the study physician and assess the severity of Pitt Hopkins 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 | Parent Global Impressions - Pitt Hopkins: Change in Symptoms (PGI-PTHS-2-Change) | End of Treatment (After 95 days of treatment) | An assessment of Pitt Hopkins Syndrome symptoms that rates the change in symptom severity since the start of treatment. Symptom severity is rated on a 7-point scale including much worse (-3), somewhat worse (-2), slightly worse (-1), no change (0), slightly better (1), somewhat better (2), and much better (3). |
| Secondary | Gastrointestinal Symptoms common in Pitt Hopkins (GI-PTHS) | Baseline (pre-treatment) vs End of Treatment (After 95 days of treatment) | Assess common symptoms in Pitt Hopkins, including 2 questions about toilet training, a question about GI feeding tubes, and 7 questions about current GI symptom severity including constipation, diarrhea, gas, bloating, pain, reflux/heartburn/regurgitation and vomiting. Symptoms are rated on a 7-point scale from none to extremely severe. |
| Secondary | Revised Face Legs Activity Crying Consolability Pain Questionnaire (FLACC) | Baseline (pre-treatment) vs End of Treatment (After 95 days of treatment) | Modified from the original FLACC for children with cognitive impairment (Malviya et al., 2006). Assess pain in five areas (Face, Legs, Activity, Crying, Consolability) using a three-point scale for each area, resulting in a total FLACC pain scale ranging from zero to 10. |
| Secondary | National Survey on treatment Effectiveness for Autism (NSTEA) - Overall Benefit | End of Treatment (After 95 days of treatment) | Assess the effectiveness of MTT on overall benefit (no benefit (0)/slight benefit(1)/moderate benefit (2)/good benefit (3)/great benefit (4)). |
| Secondary | National Survey on treatment Effectiveness for Autism (NSTEA) - Overall Adverse E | End of Treatment (After 95 days of treatment) | Assess the effectiveness of MTT on overall adverse effects of treatment (no adverse effects (0)/mild adverse effects (1)/moderate adverse effects (2)/severe adverse effects (3)). |
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.
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/NCT06321796
GET https://conductscience.org/api/trials/v1/NCT06321796/registered