protocolSection identificationModule nctId: NCT06321796, orgStudyIdInfo id: WCG IRB Protocol #20235847, briefTitle: Microbiota Transfer Therapy for Children and Adults With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Gut-Brain-Axis Therapeutics Inc., class: OTHER, collaborators name: Pitt Hopkins Research Foundation, descriptionModule briefSummary: The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating patients with Pitt-Hopkins Syndrome (PTHS) and gastrointestinal problems (constipation, bloating, abdominal pain). MTT involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by 1 day of bowel cleanse using magnesium citrate, followed by 4 days of high dose MTP-101P with an antacid, followed by 12 weeks of a lower maintenance dose of MTP-101P with an antacid., conditionsModule conditions: Pitt Hopkins Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Part 1: Randomized, Double-Blinded, Placebo-Controlled Treatment (14 weeks) Part 2: Open-Label Observation and Cross-over or Treatment Part 3: Follow Up (Group B Only), primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: MTP-101P, interventions name: Vancomycin, interventions name: Magnesium Citrate, interventions name: Antacid, interventions name: Placebo MTP-101P, interventions name: Placebo Vancomycin, outcomesModule primaryOutcomes measure: Daily Stool Record (DSR), primaryOutcomes measure: Safety Measures (Adverse Events), secondaryOutcomes measure: Gastrointestinal Symptom Rating Scale (GSRS), secondaryOutcomes measure: Clinical Global Impression - Gastrointestinal (CGI-GI), secondaryOutcomes measure: Clinical Global Impression - Pitt Hopkins (CGI-PTHS), secondaryOutcomes measure: Parent Global Impressions - Pitt Hopkins: Change in Symptoms (PGI-PTHS-2-Change), secondaryOutcomes measure: Gastrointestinal Symptoms common in Pitt Hopkins (GI-PTHS), secondaryOutcomes measure: Revised Face Legs Activity Crying Consolability Pain Questionnaire (FLACC), secondaryOutcomes measure: National Survey on treatment Effectiveness for Autism (NSTEA) - Overall Benefit, secondaryOutcomes measure: National Survey on treatment Effectiveness for Autism (NSTEA) - Overall Adverse E, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Autism/Asperger's Research Group at Arizona State University, status: RECRUITING, city: Tempe, state: Arizona, zip: 85287, country: United States, contacts name: James Adams, Phd, role: CONTACT, phone: 480-818-0741, email: jim.adams@asu.edu, contacts name: Jasmine Kirby, MS, role: CONTACT, phone: 4802343767, email: jkkirby1@gmail.com, contacts name: James Adams, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Rosa Krajmalnik-Brown, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 33.41477, lon: -111.90931, hasResults: False