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

NCT04940468 | Terminated DMC

• 3 other identifiers: 21-2851.ccP30CA046934U01AI150589-01A1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Leukemia, Lymphocytic, Acute; Leukemia, Myeloid, Acute; Lymphoma; Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• C. difficile toxins A and B

  6 weeks

• Fecal microbiome

  6 weeks

Study Arms (2)

Arm 1: Diet Intervention

ACTIVE COMPARATOR

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

Arm 2: No Diet Intervention

NO INTERVENTION

No diet changes will be made for participants

Interventions

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.

Arm 1: Diet Intervention

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years old or older
• th 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Lymphoma; Clostridium Infections

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Catherine Lozupone

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: October 21, 2022
• Primary Completion: July 2, 2025
• Study Completion: January 12, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)