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NCT04132427 · ClinicalTrials.gov registry record · Phase 2
MTT for Children With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders
A Phase 2 study, sponsored by Arizona State University.
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT04132427 is a Phase 2 study that has completed, run by Arizona State University. The registered enrollment target is 6 participants.
The verdict
NCT04132427, a Phase 2 study, has completed, sponsored by Arizona State University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study 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 (IBS). MTT involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by a bowel cleanse, followed by 12 weeks of Fecal Microbiota (FM).
Interventions
- COMBINATION_PRODUCT vancomycin, magnesium citrate, microbiota
- COMBINATION_PRODUCT placebo vancomycin, real magnesium citrate, placebo microbiota
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2022-04-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04132427
The ClinicalTrials.gov registry entry for NCT04132427 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arizona State University, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which vancomycin, magnesium citrate, microbiota is the first listed.
NCT04132427 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04132427 about?
NCT04132427 is a clinical study titled "MTT for Children With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders". 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 (IBS). MTT involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bacte...
What is the current status of trial NCT04132427?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2019-09-30. Estimated completion is 2022-04-15.
What interventions are being tested in trial NCT04132427?
The interventions under investigation include: vancomycin, magnesium citrate, microbiota (COMBINATION_PRODUCT), placebo vancomycin, real magnesium citrate, placebo microbiota (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04132427?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
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