What side effects are associated with this type of intervention?

Common treatments for Clostridium Difficile Infection (CDI) include antibiotics like vancomycin and metronidazole, which can cause side effects such as nausea, a metallic taste, and, less commonly, neurotoxicity or nephrotoxicity. Probiotics, often used to restore gut microbiota, may cause mild gastrointestinal symptoms like bloating and gas. Dietary interventions, such as increasing fiber and decreasing fat, aim to improve gut health but can initially lead to increased bloating, gas, and changes in bowel habits as the body adjusts. It is important to monitor these side effects and consult with a healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Clostridium Difficile Infection (CDI), including oral vancomycin and fidaxomicin. Vancomycin is often used in a suppressive manner for patients at high risk of recurrence, while fidaxomicin is another antibiotic option. Fecal microbiota transplantation (FMT) has also shown high efficacy in preventing CDI recurrence. Current studies are exploring dietary interventions, such as increasing fiber and decreasing fat, to improve gut microbiota and reduce CDI recurrence, although these approaches are not yet FDA-approved.

What other types of research exist?

Promising novel alternatives to dietary intervention for CDI patients include: 1) Probiotics, particularly strains of Lactobacillus and Bifidobacterium, which have shown potential in reducing CDI recurrence. 2) Fecal Microbiota Transplantation (FMT), which has demonstrated efficacy in restoring healthy gut microbiota and reducing CDI recurrence. 3) Prebiotics, such as fructooligosaccharides, which may help in modulating gut microbiota. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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High-Fiber/Low-Fat Diet for C. diff Infection Prevention in Cancer Patients

N/A

Recruiting

Led By Catherine Lozupone

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 9 years or older

Diagnosis of a malignant neoplasm at the Children's Hospital Colorado or the University of Colorado Hospital

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Summary

This trial is testing if a diet with more fiber and less fat can help prevent C. difficile infections from coming back in cancer patients. The idea is that this diet might improve gut health by supporting good bacteria and reducing bad bacteria.

Who is the study for?

This trial is for oncology patients aged 9 or older at Children's Hospital Colorado or the University of Colorado Hospital, diagnosed with acute leukemia or lymphoma and a first-time or recurrent C. difficile infection. Participants must be able to follow the study plan and have specific dietary habits based on a questionnaire.

What is being tested?

The study aims to see if changing diet by increasing fiber intake and reducing fat can prevent the recurrence of C. difficile infections in cancer patients undergoing treatment.

What are the potential side effects?

Since this is a dietary intervention, side effects may include changes in bowel habits, such as increased gas, bloating, or altered stool consistency due to higher fiber intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 9 years old or older.

Select...

I was diagnosed with cancer at Children's Hospital Colorado or University of Colorado Hospital.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

C. difficile infection recurrence (yes/no)

Secondary outcome measures

C. difficile toxins A and B

Fecal microbiome

Trial Design

2Treatment groups

Active Control

Group I: Arm 1: Diet InterventionActive Control1 Intervention

Based on participant food preferences, diet higher in fiber and lower in fat than the participant's typical diet will be provided.

Group II: Arm 2: No Diet InterventionActive Control1 Intervention

No diet changes will be made for participants

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Clostridium Difficile Infection (CDI) include antibiotics like fidaxomicin and vancomycin, and dietary interventions aimed at improving gut microbiota. Fidaxomicin works by inhibiting bacterial RNA synthesis, leading to the death of C. difficile with minimal disruption to the gut microbiome, which is crucial for preventing recurrence. Vancomycin, another antibiotic, inhibits cell wall synthesis in bacteria but can disrupt the gut microbiota more than fidaxomicin. Dietary interventions, such as increasing fiber and decreasing fat, aim to enhance gut microbiota diversity and health, potentially reducing the risk of CDI recurrence. These treatments are important as they not only target the infection but also help maintain or restore a healthy gut microbiome, which is essential for preventing future infections.