Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-01-01 @ 10:02 AM
Study NCT ID:
NCT04940468
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2021-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Do Decreased Dietary Fat and Increased Fiber Reduce Recurrence of Clostridioides Difficile Infection in Oncology Patients?
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA046934 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01AI150589-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |