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

Not Applicable

Recruiting

• Conditions: Lymphoma; Leukemia, Lymphocytic, Acute; Leukemia, Myeloid, Acute; Clostridium Difficile Infection
• Interventions: Other: Diet Intervention

• Registration Number: NCT04940468
• Lead Sponsor: University of Colorado, Denver

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.

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 Timeline

• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-25
• Study Start: 2022-10-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-12-18
• Study Completion: 2025-12-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Diet Intervention	Diet Intervention	Based on participant food preferences, diet higher in fiber and lower in fat than the participant's typical diet will be provided.

Primary Outcome Measures

Name	Time	Method
C. difficile infection recurrence (yes/no)	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 Outcome Measures

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

Trial Locations

Locations (2)

Childrens Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States