Lymphoma Clinical Trial
Official title:
Do Decreased Dietary Fat and Increased Fiber Reduce Recurrence of Clostridioides Difficile Infection in Oncology Patients?
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Childrens Hospital Colorado | Aurora | Colorado |
United States | University of Colorado Hospital | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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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