20 Participants NeededMy employer runs this trial

Diet and Health Counseling for C. diff Infection

KN
Overseen ByKira Newman, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
Must be taking: Fidaxomicin, Vancomycin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different diets might aid individuals with Clostridioides difficile infection (CDI), a gut infection that can cause severe diarrhea. Participants will receive meals and health counseling to determine if these changes can prevent recurrence. The study involves testing various diets, including an experimental one, but the specific diets will remain undisclosed until the end. Individuals with CDI who haven't experienced the infection in the last three months and are currently undergoing treatment might be suitable candidates. Participants will need to provide stool samples and complete questionnaires during the study. As an unphased study, this trial allows participants to contribute to innovative research that could lead to new dietary strategies for managing CDI.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be willing to stop probiotic supplements during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that changing one's diet might help lower the risk of recurrent C. difficile infections. One study found that only 1.5% of participants who changed their diet experienced the infection again, compared to 4% of those who did not, indicating a 60% reduction in risk due to dietary changes. However, limited information exists on the safety of these experimental diets for C. difficile. This trial is labeled as "Not Applicable" for phase, focusing on observing effects rather than testing new drugs. This generally suggests lower safety risks, particularly since the main focus is on dietary changes.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a non-traditional approach to managing C. diff infections through diet and health counseling. Unlike standard treatments, which typically involve antibiotics like vancomycin or fidaxomicin, this trial investigates whether dietary changes and lifestyle guidance can play a role in infection management. This approach could offer a way to support gut health and potentially reduce reliance on antibiotics, which can sometimes lead to resistance or other side effects. By focusing on diet, researchers aim to uncover new methods to complement existing treatments and improve patient outcomes.

What evidence suggests that this trial's treatments could be effective for C. diff infection?

This trial will compare an experimental diet with a control diet, both accompanied by health counseling, to manage Clostridioides difficile infections (CDI). Research has shown that diet might help manage CDI. Studies indicate that dietary changes can improve gut health and may reduce the risk of CDI recurrence. Treatments targeting gut bacteria have reduced CDI recurrence by 68%, suggesting that diet, which also affects gut bacteria, could be beneficial. Although most evidence comes from animal studies, the potential for diet to aid in CDI management remains promising.24678

Who Is on the Research Team?

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Kira Newman, MD, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults who have had a C. difficile infection (CDI). Participants must be able to take part in counseling sessions by phone or video and follow provided meal plans. People with certain health conditions or dietary restrictions may not be eligible.

Inclusion Criteria

I am currently being treated or will soon start treatment for C. difficile infection.
Provision of signed and dated informed consent form
I have taken fidaxomicin or vancomycin for 10-14 days to treat CDI.
See 3 more

Exclusion Criteria

Unable to provide a stool sample of appropriate quality for further analysis including low volume, adulterated, or delayed return
Pregnancy or breast-feeding
Unwillingness to stop probiotic supplements during the study period
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive meals for two weeks and continue similar meals for 6 more weeks with health counseling

8 weeks
Counseling visits by phone or online videoconference

Follow-up

Participants are monitored for changes in microbiome and quality of life

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Diet (experimental diet)
  • Health counseling sessions

Trial Overview

The study compares two different diets, along with health counseling, to see how they affect gut bacteria and the risk of getting another C. diff infection. Meals are provided for two weeks, followed by six weeks of similar self-prepared meals.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Experimental Diet plus health counselingExperimental Treatment1 Intervention
Group II: Diet (control diet per protocol) plus health counselingExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Michigan Nutrition Obesity Research Center

Collaborator

Citations

The Impact of Diet on Clostridioides difficile Infection: A Review

Although much of the data currently originates from animal models, there is growing evidence of the ability of diet to impact CDI-related outcomes. This review ...

Predicting Clostridioides difficile infection outcomes with ...

Clostridioides difficile infection results in life-threatening short-term outcomes and the potential for subsequent recurrent infection. Predicting these ...

Microbiota-Based Therapies Show Superior Outcomes for ...

Microbiota-based products showed similar efficacy, with relative risk reduction of recurrence up to 68%. Safety outcomes were favorable over a 5 ...

About C. diff

C. diff is a bacterium (germ) that causes diarrhea and inflammation of the colon. C. diff infection can be life-threatening.

Clostridioides difficile Infection: Is There a Role for Diet and ...

There is a paucity of high-quality clinical trial data of probiotics in CDI, and most studies are underpowered, with CDI as a secondary outcome in studies done ...

Clostridioides difficile infection: history, epidemiology, risk ...

Furthermore, food products such as meat, fish, and vegetables could be potential sources of exposure to C. difficile by the fecal-oral route. Direct ...

Clostridioides difficile Infection: Is There a Role for Diet and ...

The incidence of CDI was 1.5% in the treatment group and 4% in the control groups, a 60% risk reduction. They concluded a modest benefit of ...

Clostridium difficile - Pathogen Safety Data Sheets

The main risk factors for C. difficile infections include frail elderly, peripartum women and children, and antibiotic therapy. The number of severe C ...