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

Recruiting at1 trial location

Overseen by Catherine Lozupone

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

Disqualifiers: Oncology patients, others

No Placebo Group

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. ^{1 2 3 4 5}

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. ^{2 4 5 6 7}

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. ^{2 4 8 9 10}

Research Team

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.

Trial 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 (Other)

Trial Overview The 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

Group I: Arm 1: Diet Intervention Active Control 1 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 Intervention Active Control 1 Intervention

No diet changes will be made for participants

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Dr. Jeanne Marrazzo

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Executive Officer since 2023

MD, MPH

Dr. H. Clifford Lane

National Institute of Allergy and Infectious Diseases (NIAID)

Chief Medical Officer

MD

Findings from Research

Epidemiological studies suggest that increasing dietary fiber intake and reducing dietary fat may help lower the risk of developing colon cancer in humans.

Among various dietary fibers, wheat bran has shown the most promise in inhibiting colon tumor development, although animal studies have produced mixed results due to methodological differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fiber and colon cancer: animal model studies. Reddy, BS.[2019]

Higher fiber intake is associated with a reduced risk of colorectal cancer (CRC), as it promotes the production of butyrate, a compound with anti-cancer properties.

Conversely, a high-fat diet increases CRC risk by enhancing the conversion of bile acids into harmful compounds like deoxycholic acid, suggesting that managing fiber and fat intake could be effective strategies for CRC prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fiber, Fat, and Colorectal Cancer: New Insight into Modifiable Dietary Risk Factors. Ocvirk, S., Wilson, AS., Appolonia, CN., et al.[2023]

Research indicates a significant link between nutrition and cancer risk, suggesting that dietary choices can influence the likelihood of developing certain cancers.

It is estimated that up to 35% of cancers could potentially be prevented through dietary modifications, such as reducing fat intake and increasing fiber consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and diet. Newell, GR.[2019]

In a study of 504 colorectal cancer (CRC) patients, those with higher dietary fiber intake (specifically in the second quartile) had a 42% lower risk of all-cause mortality and a 58% lower risk of CRC-specific mortality compared to those with the lowest intake.

A meta-analysis of multiple studies indicated that for every 10 g/day increase in dietary fiber, there was a 16% decrease in total mortality risk among CRC patients, with maximum benefits for CRC-specific mortality observed at around 22 g/day of fiber intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Zhao, J., Zhu, Y., Du, M., et al.[2022]

In a study involving eight healthy volunteers, a high fat and high dietary fiber diet (HFF) for 10 days led to increased fecal weight and lower fecal pH compared to low fat and low dietary fiber (LF) and high fat and low dietary fiber (HF) diets, indicating improved fecal properties.

Despite changes in diet composition, the overall fecal flora remained stable, with only a slight increase in lactobacilli during the high fat period, suggesting that dietary fat and fiber levels may not significantly alter gut bacteria at the group level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dietary fat and fiber on fecal flora, bacterial metabolites, and fecal properties in Japanese volunteers. Sugawara, M., Suzuki, K., Endo, K., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Does a neutropenic diet reduce adverse outcomes in patients undergoing chemotherapy? [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Dietary fiber and cancer prevention. [2017]

3. England pubmed.ncbi.nlm.nih.gov

The benefit of the neutropenic diet: fact or fiction? [2022]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. England pubmed.ncbi.nlm.nih.gov

Large bowel cancer: prospects for control. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Dietary fiber and colon cancer: animal model studies. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Fiber, Fat, and Colorectal Cancer: New Insight into Modifiable Dietary Risk Factors. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Nutrition and diet. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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]

10. Japan pubmed.ncbi.nlm.nih.gov

Effect of dietary fat and fiber on fecal flora, bacterial metabolites, and fecal properties in Japanese volunteers. [2019]