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OpenTrials
Completed

NCT Number: NCT04940468

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

The primary objective of the study is to determine whether dietary intervention to increase fiber and decrease fat reduces C. difficile infection recurrence in a cohort of oncology patients.

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Key information

About this study

This is a randomized study. A total of 124 individuals with either acute leukemia or lymphoma and a first or second occurrence of C. difficile infection will be enrolled. Participants will be randomized to Arm 1 (Diet intervention) or Arm 2 (No diet intervention). Participants in Arm 1 will be assessed for food preferences and will be provided lists of high fiber and high saturated fats. Participants will be able to choose foods from the high fiber food lists and groceries will be provided once per week to support each participant's meal plan. Participants will be asked to limit foods on the high saturated fats list. Food consumption with a 24 hour recall and weight will be monitored and stool samples will be collected one time per week for 6 weeks. In Arm 2, participants will be asked to provide 24 hour food recall and stool samples. Individuals in both arms will be monitored for stool consistency and any antibiotics or chemotherapy drugs taken. Participation will last 6 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet intervention

Other

The dietary fiber intake target will be 19 g/d for ages 9-18 and females age 19 and older and 23g/d for males age 19 and older.

Primary outcomes

  1. C. difficile infection recurrence (yes/no)

    Time frame: 6 months

    Signs of active diarrhea using Bristol stool scale. The Bristol stool form scale includes seven types of stool which ranging from constipation (type 1) to diarrhea (type 7).

Secondary outcomes

  1. C. difficile toxins A and B

    Time frame: 6 weeks

    Quantify toxins in stool using "Separate detection of C. difficile toxins A and B" kit (tgc Biomics)

  2. Fecal microbiome

    Time frame: 6 weeks

    Characterize the microbiome in fecal samples as using 16S rRNA targeted and shotgun metagenomic sequencing

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Do Decreased Dietary Fat and Increased Fiber Reduce Recurrence of Clostridioides Difficile Infection in Oncology Patients?

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 25, 2021
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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