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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT04940468

Collaborator

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

124

Enrollment

Locations

Arms

34.3

Anticipated Duration (Months)

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Lymphocytic, Acute Leukemia, Myeloid, Acute Lymphoma Clostridium Difficile Infection	Other: Diet Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 10, 2022

Anticipated Primary Completion Date :

Mar 18, 2024

Anticipated Study Completion Date :

Mar 18, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of acute lymphocytic or myelocytic leukemia or lymphoma 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 7 days
Informed consent and assent obtained and signed.
At least 9 years old.
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.