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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: Completed Phase 2 study, sponsored by Arizona State University.
NCT04132427 is a Phase 2 study that has completed, run by Arizona State University. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The DSR is a daily record of their bowel movements including Bristol Stool Form scale. It is rated as the number of days (out of 14 days) with an abnormal report (abnormal stool, no stool, or the use of a gastrointestinal treatment). A higher percentage indicates worse symptoms.
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 |
What the finished NCT04132427 record still lists
NCT04132427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which vancomycin, magnesium citrate, microbiota is the first listed.
NCT04132427 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04132427's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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