Status:
COMPLETED
MTT for Children With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders
Lead Sponsor:
Arizona State University
Collaborating Sponsors:
Pitt Hopkins Research Foundation
Conditions:
Pitt Hopkins Syndrome
Eligibility:
All Genders
7-17 years
Phase:
PHASE2
Brief Summary
The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating patients with Pitt Hopkins Syndrome (PTHS) and gastrointestinal problems similar to Irritable Bowel Syndrome (IB...
Detailed Description
For children ages 5-17 years with PTHS and gastrointestinal problems, a Phase 2 clinical trial will evaluate the safety, tolerability, and efficacy of MTT. Randomized, double-blind, placebo-Controlle...
Eligibility Criteria
Inclusion
- Children ages 7-17 years with Pitt Hopkins Syndrome (verified by genetic testing)
- GI disorder as defined below that has lasted for at least 2 years.
- No changes in medications, supplements, diet, or therapies in last 2 months, and no intention to change them during the Parts 1 and 2 of the clinical trial.
- Ability to swallow pills (without chewing)
- Review of last two years of medical records by the study physician.
Exclusion
- Antibiotics in last 3 months
- Probiotics in last 2 months, or fecal transplant in last 12 months
- Tube feeding
- Severe gastrointestinal problems that require immediate treatment (life-threatening)
- Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions
- Unstable, poor health (based on study physician's opinion)
- Recent or scheduled surgeries
- Current participation in other clinical trials
- Females who are pregnant or who are at risk of pregnancy and sexually active without effective birth control.
- Allergy or intolerance to vancomycin or magnesium citrate
- Clinically significant abnormalities at baseline on two blood safety tests: Comprehensive Metabolic Panel, and Complete Blood Count with Differential.
- Evidence of significant impairment of immune system, or taking medications that can compromise the immune system, and thus increase risk if exposed to multiple-drug resistant bacteria.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04132427
Start Date
September 30 2019
End Date
April 15 2022
Last Update
August 26 2024
Active Locations (1)
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1
Arizona State University
Tempe, Arizona, United States, 85284