Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT02318992
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2014-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
Official Title:
Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03786900
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: