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

Last updated: January 13, 2026
Sponsor: University of Colorado, Denver
Overall Status: Terminated

Phase

N/A

Condition

Clostridium Difficile-associated Diarrhea

Gastroenteritis

Lymphoma

Treatment

Diet Intervention

Clinical Study ID

NCT04940468
21-2851.cc
U01AI150589-01A1
P30CA046934
  • Ages > 9
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: Diet Intervention
Phase:
Study Start date:
October 21, 2022
Estimated Completion Date:
January 12, 2026

Study Description

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.

Connect with a study center

  • Childrens Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Childrens Hospital Colorado

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • University of Colorado Hospital

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

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