124 Participants Needed

High-Fiber/Low-Fat Diet for C. diff Infection Prevention in Cancer Patients

Recruiting at 1 trial location
CL
Overseen ByCatherine Lozupone
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing if a diet with more fiber and less fat can help prevent C. difficile infections from coming back in cancer patients. The idea is that this diet might improve gut health by supporting good bacteria and reducing bad bacteria.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of a high-fiber/low-fat diet for preventing C. diff infections in cancer patients?

Research suggests that a high-fiber diet can protect against various cancers, and a low-fat diet is associated with lower cancer risk, which may indirectly support the idea that such a diet could help prevent infections like C. diff in cancer patients by promoting overall gut health.12345

Is a high-fiber/low-fat diet safe for humans?

A high-fiber/low-fat diet is generally considered safe for humans and has no obvious adverse effects, according to research. It may also offer protective benefits against certain types of cancer, such as colon cancer.24567

How does the High-Fiber/Low-Fat Diet treatment for C. diff infection prevention in cancer patients differ from other treatments?

The High-Fiber/Low-Fat Diet treatment is unique because it focuses on dietary modification to prevent C. diff infections, unlike standard treatments that typically involve antibiotics. This approach leverages the protective effects of high fiber and low fat, which have been associated with reduced cancer risk and improved gut health.248910

Research Team

CL

Catherine Lozupone

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for oncology patients aged 9 or older at Children's Hospital Colorado or the University of Colorado Hospital, diagnosed with acute leukemia or lymphoma and a first-time or recurrent C. difficile infection. Participants must be able to follow the study plan and have specific dietary habits based on a questionnaire.

Inclusion Criteria

I am 9 years old or older.
I was diagnosed with cancer at Children's Hospital Colorado or University of Colorado Hospital.
I have been diagnosed with my first or first recurrent C. diff infection within the last 21 days.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a diet intervention or no diet intervention for 6 weeks. In the diet intervention arm, participants receive a diet higher in fiber and lower in fat, with weekly grocery support. In both arms, food consumption, weight, and stool samples are monitored weekly.

6 weeks
6 visits (in-person)

Follow-up

Participants are monitored for C. difficile infection recurrence and stool consistency for an additional period after the treatment phase.

6 months

Treatment Details

Interventions

  • High-Fiber/Low-Fat Diet
Trial OverviewThe study aims to see if changing diet by increasing fiber intake and reducing fat can prevent the recurrence of C. difficile infections in cancer patients undergoing treatment.
Participant Groups
2Treatment groups
Active Control
Group I: Arm 1: Diet InterventionActive Control1 Intervention
Based on participant food preferences, diet higher in fiber and lower in fat than the participant's typical diet will be provided.
Group II: Arm 2: No Diet InterventionActive Control1 Intervention
No diet changes will be made for participants

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

Findings from Research

In a study of 154 chemotherapy patients, those on a neutropenic diet (ND) experienced higher rates of febrile neutropenia and bacteraemia compared to those on a liberalised diet (LD), suggesting that ND may not be beneficial for infection prevention.
Despite the higher incidence of infections in the ND group, a matched analysis of 20 pairs of patients showed no significant differences in clinical outcomes between the ND and LD groups, indicating that ND does not independently prevent adverse outcomes in neutropenic patients.
Does a neutropenic diet reduce adverse outcomes in patients undergoing chemotherapy?Heng, MS., Barbon Gauro, J., Yaxley, A., et al.[2020]
A high-fiber diet is associated with a reduced risk of several cancers, particularly colon cancer, with 25 out of 32 studies showing this protective effect since 1980.
While many studies indicate that fiber-rich foods may lower cancer risk, it's challenging to determine if fiber alone is responsible for this effect, suggesting that overall dietary patterns are more important than just fiber supplements.
Dietary fiber and cancer prevention.Shankar, S., Lanza, E.[2017]
The effectiveness of neutropenic diets for cancer patients has not been scientifically proven, despite their continued use in many healthcare institutions, originally thought to protect against infections during chemotherapy.
Recent studies show no significant differences in infection rates between patients on neutropenic diets and those on regular diets, highlighting the need for better food safety guidelines rather than restrictive diets.
The benefit of the neutropenic diet: fact or fiction?Jubelirer, SJ.[2022]

References

Does a neutropenic diet reduce adverse outcomes in patients undergoing chemotherapy? [2020]
Dietary fiber and cancer prevention. [2017]
The benefit of the neutropenic diet: fact or fiction? [2022]
Effect of beta-carotene and wheat bran fiber on colonic aberrant crypt and tumor formation in rats exposed to azoxymethane and high dietary fat. [2019]
Large bowel cancer: prospects for control. [2017]
Dietary fiber and colon cancer: animal model studies. [2019]
Fiber, Fat, and Colorectal Cancer: New Insight into Modifiable Dietary Risk Factors. [2023]
Nutrition and diet. [2019]
Association between Dietary Fiber Intake and Mortality among Colorectal Cancer Survivors: Results from the Newfoundland Familial Colorectal Cancer Cohort Study and a Meta-Analysis of Prospective Studies. [2022]
Effect of dietary fat and fiber on fecal flora, bacterial metabolites, and fecal properties in Japanese volunteers. [2019]