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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04940468
Other study ID # 21-2851.cc
Secondary ID P30CA046934U01AI
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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