TERMINATED

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

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Conditions

Leukemia, Lymphocytic, AcuteLeukemia, Myeloid, AcuteLymphomaClostridium Difficile Infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-21
Study Completion:2026-01-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04940468

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:9 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of a malignant neoplasm at the at Children's Hospital Colorado or the University of Colorado Hospital
  2. * Diagnosis of first time or first recurrent CDI as defined by clinical criteria within the past 21 days
  3. * 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.
  4. * 9 years old or older
  5. * 40th to 100th percentiles of saturated fat intake and below the 50th percentile for fiber intake based on a food frequency questionnaire.
  6. * Ability to comply with study procedures for the entire length of the study.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Catherine Lozupone
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

Childrens Hospital Colorado
Aurora, Colorado, 80045
United States
University of Colorado Hospital
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Catherine Lozupone, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-21
Study Completion Date2026-01-12

Study Record Updates

Study Start Date2022-10-21
Study Completion Date2026-01-12

Terms related to this study

Additional Relevant MeSH Terms

  • Leukemia, Lymphocytic, Acute
  • Leukemia, Myeloid, Acute
  • Lymphoma
  • Clostridium Difficile Infection