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Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

Recurrent Clostridium Difficile Infection Clinical Trial

Official title:
Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

Clinical Trial Summary

Recurrent Clostridioides difficle infection (rCDI) is a very significant problem in its own right and current fecal microbiota transplant (FMT) -based therapeutics will benefit from their optimization for this indication. It is likely that appropriate nutritional support coupled with microbiota-based drugs will yield superior clinical outcomes. However, both diet and gut microbiome are very complex. This project, which is based on a wealth of FMT experience, both clinical and investigational, over the past decade along with the novel techniques developed to identify dietary patterns and food groups that explain the most variation in gut microbiome, offers an ideal platform for performing systematic research in nutritional support that promotes gut microbiota health. The purpose is to Generate preliminary data with regards to tolerability of the Microbiota enhancing and nourishing diet (MEND) and its effects on the fecal microbiota in rCDI patients following FMT with the goal of developing larger clinical trials aimed to optimize post-FMT dietary management.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05826418
Study type Interventional
Source University of Minnesota
Contact Alexander Khoruts, MD
Phone 612-625-8999
Email khoru001@umn.edu
Status Recruiting
Phase N/A
Start date May 1, 2023
Completion date August 1, 2025
View Details
See also
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Terminated NCT01226992 - Oral Vancomycin Followed by Fecal Transplant Versus Tapering Oral Vancomycin Phase 2/Phase 3
Not yet recruiting NCT04960306 - Fecal Filtrate as a Treatment Option of Multiple Recurrent Clostridioides Difficile Infection Phase 3
Completed NCT03462459 - Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection Phase 2
Recruiting NCT06237452 - VE303 for Prevention of Recurrent Clostridioides Difficile Infection Phase 3
Completed NCT03497806 - Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection Phase 2
Suspended NCT01202630 - BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection Phase 3
Terminated NCT03973697 - Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection Phase 2
Completed NCT03353506 - Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection Phase 2
Completed NCT01925417 - Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea Phase 2
Available NCT03786900 - Fecal Microbiota Transplantation (FMT): PRIM-DJ2727