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NCT02423967 · ClinicalTrials.gov registry record · Phase 1
Fresh Versus Frozen Stool for Fecal Transplant in Children
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT02423967: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT02423967 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02423967, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The primary goal of this study will be to assess whether stool collected and frozen from anonymous screened unrelated donors can be as effective as stool freshly collected from recipient's parents when used in Fecal Microbial Transplant for the eradication of recurrent Clostridium difficile infections in children. In the current protocols, which are more than 90% effective, each child who is receiving a fecal transplant has to provide their own donor stool, usually from a parent or close relative. This requires considerable screening costs for each case and is logistically complicated as the donor must be present and must stool just prior to the transplant. The investigators hope to show that a small number of healthy donors can provide stool samples which can be frozen and banked and then thawed for use in numerous patients. The primary goal is to show that Clostridium difficile will be eradicated as effectively (Greater than 90% success) when using the stool from the frozen donors. The study will also evaluate the inflammatory response and intestinal microbiome in young children aged 1-3 years with Clostridium difficile infections to better predict which ones will respond to fecal transplantation and which ones have incidental infections. For this question the investigators will gather stool samples to check for lactoferrin, calprotectin, and alpha1antitrypsin, and 16s ribosomal RNA analysis in children before and after the fecal transplants. The goal is to see if there is an intestinal microbiome that predisposes some children to getting sick from Clostridium difficile versus just having it incidentally.
Interventions
- BIOLOGICAL Transplant uses frozen anonymous stool
- BIOLOGICAL Transplant uses fresh familial stool
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2015-04 |
| Est. Completion | 2019-03-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02423967
The ClinicalTrials.gov registry entry for NCT02423967 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Transplant uses frozen anonymous stool is the first listed.
NCT02423967 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02423967 about?
NCT02423967 is a clinical study titled "Fresh Versus Frozen Stool for Fecal Transplant in Children". The primary goal of this study will be to assess whether stool collected and frozen from anonymous screened unrelated donors can be as effective as stool freshly collected from recipient's parents when used in Fecal Microbial Transplant for the eradication of recurrent Clostridium difficile infectio...
What is the current status of trial NCT02423967?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2015-04. Estimated completion is 2019-03-04.
What interventions are being tested in trial NCT02423967?
The interventions under investigation include: Transplant uses frozen anonymous stool (BIOLOGICAL), Transplant uses fresh familial stool (BIOLOGICAL).
Who is sponsoring clinical trial NCT02423967?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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