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Search / Trial NCT04940468

High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology

Launched by UNIVERSITY OF COLORADO, DENVER · Jun 17, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at whether a diet high in fiber and low in fat can help prevent a serious infection called Clostridioides difficile (C. difficile) from coming back in patients with certain types of cancer, like leukemia and lymphoma. The researchers want to see if changing what patients eat can make a difference in their health and help them avoid getting this infection again.

To join the study, participants need to be 9 years old or older and have been recently diagnosed with a cancer that is being treated at Children's Hospital Colorado or the University of Colorado Hospital. They should also have had their first or a repeat C. difficile infection within the last 21 days. Participants will need to be willing to follow the study’s diet plan and be able to commit to the study for its entire duration. If you or a loved one meet these criteria, you could help researchers learn more about how diet can impact recovery from infections in cancer patients.

Gender

ALL

Eligibility 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.

About University Of Colorado, Denver

The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.

Locations

Aurora, Colorado, United States

Aurora, Colorado, United States

Patients applied

0 patients applied

Trial Officials

Catherine Lozupone

Principal Investigator

University of Colorado, Denver

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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