Diet changes to prevent recurrent C. difficile infections in cancer patients
Do Decreased Dietary Fat and Increased Fiber Reduce Recurrence of Clostridioides Difficile Infection in Oncology Patients?
This study is testing if a high-fiber, low-fat diet can help cancer patients with leukemia or lymphoma avoid getting C. difficile infections again.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 9 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT04940468 on ClinicalTrials.gov |
What this trial studies
This randomized study aims to evaluate whether a high-fiber, low-fat diet can reduce the recurrence of Clostridioides difficile infection (CDI) in oncology patients with acute leukemia or lymphoma. A total of 124 participants will be enrolled and randomly assigned to either a diet intervention group or a control group. The diet intervention group will receive weekly grocery support and guidance on food choices, while both groups will provide dietary recalls and stool samples for analysis. The study will last for 6 weeks, monitoring food intake, stool consistency, and any medications taken.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 9 years and older with a diagnosis of acute leukemia or lymphoma and a recent occurrence of CDI.
Not a fit: Patients who do not have a recent CDI or those with dietary restrictions that prevent adherence to the study diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of CDI in patients undergoing treatment for cancer.
How similar studies have performed: While dietary interventions have been explored in various contexts, this specific approach targeting CDI recurrence in oncology patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of a malignant neoplasm at the at Children's Hospital Colorado or the University of Colorado Hospital * Diagnosis of first time or first recurrent CDI as defined by clinical criteria within the past 21 days * Informed consent obtained and signed. For minors, the consent will be completed by a guardian and the study participant will sign the assent form. Only the consent form is required of adults. * 9 years old or older * 40th to 100th percentiles of saturated fat intake and below the 50th percentile for fiber intake based on a food frequency questionnaire. * Ability to comply with study procedures for the entire length of the study.
Where this trial is running
Aurora, Colorado and 1 other locations
- Childrens Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- University of Colorado Hospital — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Catherine Lozupone — University of Colorado, Denver
- Study coordinator: Catherine Lozupone
- Email: Catherine.Lozupone@cuanschutz.edu
- Phone: 303-724-7942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.