Specialized Diets for Clostridium Difficile Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are expected to take antibiotics during the study, you would be excluded from participating.
Is the MEND diet safe for humans?
Research on specialized diets for Clostridium difficile infection (CDI) in mice suggests that high-fat diets can worsen CDI, while high-carbohydrate diets may offer protection. Although these findings are from animal studies, they highlight the potential impact of diet on gut health and CDI, suggesting that dietary interventions could be safe and beneficial, but human studies are needed for confirmation.12345
How does the specialized diet treatment for Clostridium difficile infection differ from other treatments?
This specialized diet treatment for Clostridium difficile infection is unique because it focuses on dietary modifications, particularly increasing high-carbohydrate and microbiota-accessible carbohydrates (MACs), which can protect against the infection by promoting beneficial gut bacteria and reducing harmful ones. Unlike traditional treatments that often involve antibiotics, this approach uses diet to influence gut health and reduce infection risk.12345
What data supports the effectiveness of the MEND diet treatment for Clostridium Difficile Infection?
Research suggests that dietary changes can impact the gut microbiome, which is important in managing Clostridium difficile infection. A high-carbohydrate diet has been shown to protect against this infection in mice, indicating that certain dietary modifications, like those in the MEND diet, might help manage the condition.12467
Who Is on the Research Team?
Alexander Khoruts, MD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for adults at least 18 years old who have had two or more recurrences of Clostridium difficile infection within a year and are planning to undergo fecal microbiota transplant (FMT) therapy. Participants must be able to follow the study requirements and give informed consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive FMT and follow a specific diet (MEND or mNICE) to optimize microbiome recovery
Follow-up
Participants are monitored for safety and effectiveness of the diet and FMT on microbiome recovery
What Are the Treatments Tested in This Trial?
Interventions
- MEND diet
- mNICE diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor