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

University of Colorado Denver (CU Denver)

Status: Terminated

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

Treatments: Other: Diet Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04940468

U01AI150589-01A1 (U.S. NIH Grant/Contract)

21-2851.cc

P30CA046934 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Arm 1: Diet Intervention

Active Comparator group

Description:

Based on participant food preferences, diet higher in fiber and lower in fat than the participant's typical diet will be provided.

Treatment:

Other: Diet Intervention

Arm 2: No Diet Intervention

No Intervention group

Description:

No diet changes will be made for participants