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

Recruiting at 1 trial location

Overseen By Catherine Lozupone

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Oncology patients, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a high-fiber, low-fat diet can prevent the recurrence of C. difficile infections, a type of gut infection, in people with cancer. Participants will either follow this special diet or maintain their usual eating habits. The study seeks cancer patients who have recently experienced a C. difficile infection and currently consume a diet high in saturated fat and low in fiber. As an unphased trial, it offers a unique opportunity for patients to contribute to research that could enhance dietary recommendations for cancer patients.

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 prior data suggests that this dietary intervention is safe for cancer patients?

Research has shown that a high-fiber diet can maintain gut health. This diet can lower certain bile acids that promote the growth of harmful bacteria like C. difficile. In contrast, animal studies have linked low-fiber, high-fat diets to a higher risk of infections.

Regarding safety, most people can adopt a high-fiber, low-fat diet without major issues. Significant side effects are not commonly reported with this dietary change, making it a safe option for reducing infection risk, including C. difficile, especially for cancer patients with weakened immune systems. While not a traditional "treatment" like medication, it is a lifestyle change with a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the high-fiber/low-fat diet intervention for preventing C. diff infections in cancer patients because it offers a natural, dietary approach that could complement or even reduce the need for antibiotics, which are the standard treatment today. Unlike antibiotics, which target bacteria directly and can disrupt the gut microbiome, this diet aims to strengthen the microbiome by providing beneficial nutrients and promoting a balanced gut environment. By enhancing the body's natural defenses through nutrition, this method could offer a safer, sustainable option with fewer side effects, especially important for vulnerable cancer patients who are often at higher risk for infections.

What evidence suggests that a high-fiber/low-fat diet could be effective for preventing C. diff infection in cancer patients?

Research has shown that a high-fiber diet might lower the risk of several types of cancer, especially colon cancer. Out of 32 studies, 25 support this protective effect. Some studies also suggest that fiber could help with Clostridioides difficile (C. diff) infections, though results are mixed. In this trial, participants in one arm will follow a high-fiber/low-fat diet intervention, which might help prevent C. diff infections from recurring in cancer patients. Evidence suggests that dietary changes could benefit those at risk of these infections. ^{1 5 6 7 8}

Who Is on the Research Team?

Catherine Lozupone

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• High-Fiber/Low-Fat Diet

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.

How Is the Trial Designed?

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+

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fiber and cancer prevention. Shankar, S., Lanza, E.[2017]

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefit of the neutropenic diet: fact or fiction? Jubelirer, SJ.[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]

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]

High dietary fat intake (40-45% of calories) is linked to an increased risk of large bowel cancer, particularly in the descending and sigmoid colon, while a high intake of cereal fibers is associated with a lower risk, as seen in Finland.

Recommendations suggest reducing fat intake to 20-25% of calories and increasing fiber intake to about 30 grams daily from whole grains and cruciferous vegetables, as these dietary changes have no obvious adverse effects and can help in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large bowel cancer: prospects for control. Wynder, EL.[2017]

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]

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]

In a study using Fischer-344 rats, increasing dietary beta-carotene significantly reduced the number of colon aberrant crypt foci (ACF), a precursor to cancer, in both low-fiber and high-fiber diets, indicating its protective effect against colon cancer.

The combination of beta-carotene and wheat bran fiber not only lowered ACF counts but also decreased colon tumor incidence from 73% to 20% in high-fiber groups, demonstrating their potential as dietary protectors against cancer in high-fat diets.

NCBI (Pubmed)

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. Alabaster, O., Tang, Z., Frost, A., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04940468

Study Details | NCT04940468 | High- Fiber/ Low-fat Diet for ... The primary objective of the study is to determine whether dietary intervention to increase fiber and decrease fat reduces C. difficile infection recurrence in ...

2. withpower.com withpower.com/trial/phase-leukemia-11-2021-fa018

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

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9682084/

The impact of dietary fibers on Clostridioides difficile infection ... Studies have reported conflicting results regarding the relationship between diet and CDI. Some have shown that dietary fiber can alleviate ...

4. clinicaltrial.be clinicaltrial.be/en/details/42390?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

High- Fiber/ Low-fat Diet for Prevention of Recurrent Clo... 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. Primary outcomes.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04940468/high-fiber-low-fat-diet-for-prevention-of-recurrent-clostridioides-difficile-infection-in-oncology

High- Fiber/ Low-fat Diet for Prevention of Recurrent ... The primary objective of the study is to determine whether dietary intervention to increase fiber and decrease fat reduces C. difficile ...

6. academic.oup.com academic.oup.com/jid/article/231/6/e1010/8124888

The Impact of Diet on Clostridioides difficile Infection: A Review Mice on the high-fat/low-fiber diet had higher levels of bile acids that promote C difficile growth and lower levels of secondary bile acids ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11324037/

Clostridioides difficile infection: history, epidemiology, risk ... In mice experimental studies, a high-fat/high-protein diet may enhance CDI risk and severity during antibiotic treatment, whereas a high-carbohydrate diet may ...

8. med.virginia.edu med.virginia.edu/ginutrition/wp-content/uploads/sites/199/2020/09/September-2020-CDiff-Diet-Probiotics.pdf

Clostridioides difficile Infection: Is There a Role for Diet and ... Select Diets. Several studies have shown the consumption of a Western diet, consisting of high animal protein and fat with low fiber has resulted in reduced.