Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation

Launched by UNIVERSITY OF MINNESOTA · Apr 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a special diet can help improve recovery after a fecal microbiota transplant (FMT) for patients with recurrent Clostridium difficile infections (rCDI). rCDI is a serious condition that causes repeated intestinal infections, and FMT is a treatment that involves transferring healthy bacteria from a donor's stool to help restore the gut's natural balance. The researchers believe that combining this transplant with the right nutrition might lead to better health outcomes for patients. The trial aims to gather initial information about how well a specific diet, called the Microbiota Enhancing and Nourishing Diet (MEND), works for people undergoing FMT.

To participate in this trial, you need to be at least 18 years old and planning to receive FMT for recurrent CDI infections, having had at least two episodes in the past year. However, certain conditions, like inflammatory bowel disease or recent stomach surgery, could prevent you from joining. If you decide to participate, you can expect to follow the MEND diet alongside your FMT treatment. The goal of this study is to gather enough information to eventually design larger trials that could help optimize dietary management for patients after FMT. Your involvement could play a crucial role in improving treatment for many others facing similar health challenges.

Gender

ALL

Eligibility 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