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Dietary change may curb recurrent c. diff in cancer patients

NCT ID NCT04940468

Disease control Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tested whether eating less fat and more fiber can reduce the chance of a repeat Clostridioides difficile infection in cancer patients. Eight participants with leukemia, lymphoma, or other cancers followed a specific diet. Researchers tracked diarrhea and measured C. diff toxins and gut bacteria in stool samples.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dietary intervention (low fat, high fiber)
What this could lead to
If successful, this could point toward a simple dietary approach to help prevent repeat C. diff infections in cancer patients.
What could go wrong
This is a very small pilot study with only 8 participants, so results may not apply broadly. Dietary changes alone may not be enough to prevent infection recurrence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

8 people

The number who actually took part.

Started

Oct 2022

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

9 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute leukemia acute lymphoblastic leukemia acute myeloid leukemia Clostridium difficile colitis Clostridium infectious disease lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clostridium difficile infection Leukemia, lymphocytic, acute Leukemia, myeloid, acute Lymphoma Solid cancers

Contacts and locations

Locations

  • Childrens Hospital Colorado

    Aurora, Colorado, 80045, United States

  • University of Colorado Hospital

    Aurora, Colorado, 80045, United States

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