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NCT02318992 · ClinicalTrials.gov registry record · Phase 1
Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea
A Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 1
- Development phase
- 79
- Enrollment target
NCT02318992 is a Phase 1 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 79 participants.
The verdict
NCT02318992, a Phase 1 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 79 participants
- Enrollment target
Study Summary
The objective of the study is to investigate the efficacy of fresh, frozen or lyophilized fecal microbiota transplantation (FMT) via colonoscopy in patients with recurrent C. difficile associated diarrhea (RCDAD). Frozen, lyophilized or fresh fecal microbiota transplantation (FMT) inoculum will be generated from well-screened healthy volunteer donors of ≥150 gram/sample. Delivery of FMT will be performed colonoscopically. Fecal samples from donors and recipients will be saved for later metagenomic studies to characterize the microbiome of the gut in patients before and after FMT.
Interventions
- BIOLOGICAL Fecal Microbiota
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2013-08 |
| Est. Completion | 2018-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02318992
The ClinicalTrials.gov registry entry for NCT02318992 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fecal Microbiota is the first listed.
NCT02318992 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02318992 about?
NCT02318992 is a clinical study titled "Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea". The objective of the study is to investigate the efficacy of fresh, frozen or lyophilized fecal microbiota transplantation (FMT) via colonoscopy in patients with recurrent C. difficile associated diarrhea (RCDAD). Frozen, lyophilized or fresh fecal microbiota transplantation (FMT) inoculum will be g...
What is the current status of trial NCT02318992?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2013-08. Estimated completion is 2018-04.
What interventions are being tested in trial NCT02318992?
The interventions under investigation include: Fecal Microbiota (BIOLOGICAL).
Who is sponsoring clinical trial NCT02318992?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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