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NCT05826418
Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation
NA trial testing MEND diet in Recurrent Clostridium Difficile Infection in 12 participants. Completed in 12 March 2024.
12 March 2024
Quick facts
| Lead sponsor | University of Minnesota |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 12 |
| Start date | 1 May 2023 |
| Primary completion | 12 March 2024 |
| Estimated completion | 12 March 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- MEND diet
- mNICE diet
Conditions studied
- Recurrent Clostridium Difficile Infection — all drugs for Recurrent Clostridium Difficile Infection →
- Fecal Microbiota Transplant — all drugs for Fecal Microbiota Transplant →
Sponsor
University of Minnesota
Who can join
18 and older, any sex, with Recurrent Clostridium Difficile Infection or Fecal Microbiota Transplant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05826418
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05826418 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Minnesota
- Last refreshed: 12 August 2025
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