Clinical trial · Interventional
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology
Do Decreased Dietary Fat and Increased Fiber Reduce Recurrence of Clostridioides Difficile Infection in Oncology Patients?
NCT04940468CI-TRIAL-00107496completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clostridium Difficile Infection | — | UNRESOLVED | — |
| Leukemia, Lymphocytic, Acute | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Leukemia, Myeloid, Acute | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Solid Cancers | Malignant Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1: Diet Intervention
- description
- Based on participant food preferences, diet higher in fiber and lower in fat than the participant's typical diet will be provided.
- interventionNames
- Other: Diet Intervention
- type
- NO_INTERVENTION
- label
- Arm 2: No Diet Intervention
- description
- No diet changes will be made for participants
Primary outcomes (1)
- measure
- Number of Participants With Recurrent C Difficile Infection
- timeFrame
- 6 weeks
- description
- Clinical diagnosis of recurrent C. difficile
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.