30 Participants Needed

Specialized Diets for Clostridium Difficile Infection

AK
Overseen ByAlexander Khoruts, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.12367

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.12367

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.

Research Team

AK

Alexander Khoruts, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

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

Informed consent
Ability to comply with study requirements
I am planning to have FMT therapy for recurring C. diff infection.

Exclusion Criteria

Ongoing alcohol or drug abuse
Pregnancy
Any reason felt by the investigator to complicate the feasibility of participation
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FMT and follow a specific diet (MEND or mNICE) to optimize microbiome recovery

4 weeks
Weekly visits for dietary monitoring and FMT administration

Follow-up

Participants are monitored for safety and effectiveness of the diet and FMT on microbiome recovery

3 months
Monthly visits for microbiome assessment

Treatment Details

Interventions

  • MEND diet
  • mNICE diet
Trial Overview The trial is testing two diets, MEND and mNICE, designed to optimize gut health after FMT in patients with recurrent C. difficile infections. The goal is to see how well these diets support recovery by nourishing the new microbiome established by FMT.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: MEND dietExperimental Treatment1 Intervention
patients being treated with FMT
Group II: mNICE (modified NICE) dietActive Control1 Intervention
patients being treated with FMT

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

C. difficile is a significant pathogen that can cause a range of conditions from asymptomatic carriage to severe colitis, with higher carriage rates in long-term care facilities (20-50%).
The study highlights a successful case where dietary modification was used to treat C. difficile colonization and recurrence, suggesting that diet may play a crucial role in managing this infection by influencing the gut microbiome.
Dietary therapy for clostridium difficile colonization: A case series.Suskind, DL., Lee, D., Solan, P., et al.[2020]
In a mouse model of antibiotic-induced Clostridioides difficile infection (CDI), high-fat/high-protein diets significantly worsened CDI outcomes, leading to 100% mortality with an Atkins-like diet, while a high-carbohydrate diet provided protection against CDI.
The study suggests that high-fat diets may promote CDI by reducing beneficial gut bacteria that compete with C. difficile, whereas high-carbohydrate diets may help maintain these protective bacteria, highlighting the importance of diet in managing CDI risk during antibiotic treatment.
A High-Fat/High-Protein, Atkins-Type Diet Exacerbates Clostridioides (Clostridium) difficile Infection in Mice, whereas a High-Carbohydrate Diet Protects.Mefferd, CC., Bhute, SS., Phan, JR., et al.[2021]
In a study using a murine model of Clostridium difficile infection (CDI), dietary supplementation with indole-3-carbinol (I3C) significantly reduced disease severity and mortality compared to a diet lacking this AHR ligand, indicating its potential as a therapeutic option.
I3C appears to enhance immune responses by increasing specific immune cell populations without causing additional inflammation, suggesting it may work through both AHR-dependent and independent mechanisms to help combat CDI.
Amelioration of Clostridium difficile Infection in Mice by Dietary Supplementation With Indole-3-carbinol.Julliard, W., De Wolfe, TJ., Fechner, JH., et al.[2020]

References

Dietary therapy for clostridium difficile colonization: A case series. [2020]
A High-Fat/High-Protein, Atkins-Type Diet Exacerbates Clostridioides (Clostridium) difficile Infection in Mice, whereas a High-Carbohydrate Diet Protects. [2021]
Amelioration of Clostridium difficile Infection in Mice by Dietary Supplementation With Indole-3-carbinol. [2020]
Changes in microbiota composition, bile and fatty acid metabolism, in successful faecal microbiota transplantation for Clostridioides difficile infection. [2020]
Staggered and tapered antibiotic withdrawal with administration of kefir for recurrent Clostridium difficile infection. [2020]
Microbiota-accessible carbohydrates suppress Clostridium difficile infection in a murine model. [2021]
Dietary fat promotes antibiotic-induced Clostridioides difficile mortality in mice. [2022]
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