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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04940468
• Other study ID #: 21-2851.cc
• Secondary ID: P30CA046934U01AI
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2022
• Est. completion date: December 18, 2025

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: Catherine Lozupone
• Phone: 303-724-7942
• Email: Catherine.Lozupone[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 18, 2025
• Est. primary completion date: December 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infections
• Leukemia
• Leukemia, Lymphocytic, Acute
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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.

Locations

Country	Name	City	State
United States	Childrens Hospital Colorado	Aurora	Colorado
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Fecal microbiome	Characterize the microbiome in fecal samples as using 16S rRNA targeted and shotgun metagenomic sequencing	6 weeks