Leukemia, Lymphocytic, AcuteNCT04940468
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology
A study testing Diet Intervention in people with Leukemia, Lymphocytic, Acute and Leukemia, Myeloid, Acute, run by University of Colorado, Denver at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Acute, Lymphoma
- What is being tested?
- Diet Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Oct 2022to 12 Jan 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Childrens Hospital Colorado
Aurora, Colorado, 80045
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
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.
Read the detailed description
This is a randomized study. A total of 124 individuals with cancer 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 foods with 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.
- Conditions
- Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Acute, Lymphoma, Clostridium Difficile Infection, Solid Cancers
- Being tested
- Diet Intervention
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Lymphoma, Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Diet Intervention | Active comparator | Based on participant food preferences, diet higher in fiber and lower in fat than the participant's typical diet will be provided. Receives: Other: Diet Intervention |
| Arm 2: No Diet Intervention | No intervention | No diet changes will be made for participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Recurrent C Difficile Infection
Clinical diagnosis of recurrent C. difficile
Measured: 6 weeks
Secondary outcomes (2)
C. Difficile Toxins A and B
Quantify toxins in stool using "Separate detection of C. difficile toxins A and B" kit (tgc Biomics)
Measured: 6 weeks
Fecal Microbiome
Characterize the microbiome in fecal samples as using 16S rRNA targeted and shotgun metagenomic sequencing
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start21 Oct 2022
- Primary completion2 Jul 2025
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Leukemia, Lymphocytic, AcuteStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Catherine Lozupone, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940468
- Sponsor's protocol ID
- 21-2851.cc
- Other IDs
- P30CA046934, U01AI150589-01A1
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2021
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No