Optimizing diet to improve recovery after fecal microbiota transplantation
Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation
This study is testing whether a special diet can help people with recurrent Clostridium difficile infections recover better after receiving a fecal microbiota transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05826418 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the recovery of gut microbiota in patients with recurrent Clostridium difficile infection (rCDI) following fecal microbiota transplantation (FMT) by implementing a specialized diet known as the Microbiota Enhancing and Nourishing Diet (MEND). The research will assess the tolerability of this diet and its effects on the gut microbiome in rCDI patients. By combining nutritional support with microbiota-based therapies, the study seeks to identify dietary patterns that can lead to improved clinical outcomes. The approach is based on extensive clinical experience and novel techniques developed over the past decade.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are planning to undergo fecal microbiota transplantation for recurrent Clostridium difficile infection.
Not a fit: Patients with underlying inflammatory bowel disease, advanced liver disease, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery and reduced recurrence rates for patients suffering from recurrent Clostridium difficile infections.
How similar studies have performed: While the combination of dietary optimization and fecal microbiota transplantation is a novel approach, previous studies have shown promise in improving outcomes with microbiota-based therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent * Clinical plans to undergo FMT therapy for treatment of rCDI (≥ 2 CDI recurrences following the initial episode within 1 year without contraindications to the treatment) * Ability to comply with study requirements * Age at least 18 years old Exclusion Criteria: * Underlying IBD * History of stomach surgery or bowel resection * Anticipated antibiotic exposure during the study period * Advanced liver disease * Ongoing alcohol or drug abuse * Pregnancy * Any reason felt by the investigator to complicate the feasibility of participation
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Alexander Khoruts, MD — University of Minnesota
- Study coordinator: Alexander Khoruts, MD
- Email: khoru001@umn.edu
- Phone: 612-625-8999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.