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

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Leukemia, Myeloid, Acute; Clostridium Difficile Infection; Leukemia, Lymphocytic, Acute
• Intervention / Treatment: Other: Diet Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
    • Aurora, Colorado, United States, 80045
      • Childrens Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Diet Intervention; Based on participant food preferences, diet higher in fiber and lower in fat than the participant's typical diet will be provided.	Other: Diet Intervention; 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.
No Intervention: Arm 2: No Diet Intervention; No diet changes will be made for participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C. difficile infection recurrence (yes/no)	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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C. difficile toxins A and B	Quantify toxins in stool using "Separate detection of C. difficile toxins A and B" kit (tgc Biomics)	6 weeks
Fecal microbiome	Characterize the microbiome in fecal samples as using 16S rRNA targeted and shotgun metagenomic sequencing	6 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI); National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Catherine Lozupone, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Actual): July 2, 2025
• Study Completion (Actual): January 12, 2026

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Infections; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Myeloid; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Clostridium Infections
• Other Study ID Numbers: 21-2851.cc; P30CA046934 (U.S. NIH Grant/Contract); U01AI150589-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No