High Dietary Fiber Formula for Colon Cancer

Recruiting at 10 trial locations

Overseen By Howard S. Hochster

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Howard S. Hochster, MD

Must be taking: Irinotecan

Must not be taking: Antibiotics

Disqualifiers: Grade 2+ diarrhea, Ulcerative colitis, Crohn's, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a high dietary fiber formula called NBT-NM108 can reduce chemotherapy-induced diarrhea in people with metastatic colon cancer. The goal is to determine if this fiber formula can help patients better tolerate irinotecan, a common treatment for colon cancer with significant side effects. Participants will receive the fiber formula alongside their chemotherapy to assess its effectiveness. Those with metastatic colon cancer starting irinotecan treatment may be suitable for this trial, particularly if they have previously experienced diarrhea returning to normal. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially benefit from an innovative approach to managing chemotherapy side effects.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently on antibiotic therapy.

Is there any evidence suggesting that NBT-NM108 is likely to be safe for humans?

Research has shown that NBT-NM108, a high-fiber formula, is generally safe for people. Designed to improve gut health, this formula has been used safely in other studies. It has received investigational new drug status from the FDA, indicating it passed initial safety checks. Participants in previous studies found relief from severe stomach issues without major side effects. While individual reactions can vary, current evidence suggests that NBT-NM108 is safe for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about NBT-NM108 for colon cancer because it introduces a high dietary fiber formula that aims to support the microbiome, unlike traditional chemotherapy that primarily focuses on attacking cancer cells directly. This treatment is unique as it could enhance the gut environment, potentially improving chemotherapy outcomes and reducing side effects. By integrating NBT-NM108 with irinotecan-based chemotherapy, there's hope for a more holistic approach that addresses both cancer and overall gut health, offering a novel pathway not typically explored in conventional treatments.

What evidence suggests that NBT-NM108 might be an effective treatment for reducing chemotherapy-induced diarrhea in metastatic colon cancer?

Research has shown that a high-fiber diet benefits gut health and might reduce chemotherapy-induced diarrhea. In this trial, one group of participants will receive NBT-NM108, a high-fiber formula designed to improve gut health. Studies have found that dietary changes can alleviate serious gut problems, such as those experienced by individuals after COVID. This suggests that NBT-NM108 might help reduce diarrhea in colon cancer patients undergoing chemotherapy. Additionally, a study from Rutgers found that a similar formula relieved long-term severe gut issues. ^{1 2 4 6 7}

Who Is on the Research Team?

Howard S Hochster, MD

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

This trial is for adults with metastatic colon cancer who are set to receive irinotecan-based chemotherapy. They must have a good performance status, meaning they're able to carry out daily activities with little or no assistance. Their blood counts and organ functions need to meet specific criteria, and they shouldn't have had irinotecan or severe diarrhea recently.

Inclusion Criteria

I am eligible for a second or later round of chemotherapy that includes irinotecan.

I don't know my UGTA1A* genotype.

Lab values as acceptable for trials: Absolute Neutrophil Count( ANC) >1500/uL; Creatinine < 1.5 x Upper Limit of Normal (ULN); Transaminases < 5x ULN; Bilirubin < 1.5 x ULN; Albumin > 3.0 g/dL

Exclusion Criteria

Inability to take oral supplements

I am currently taking antibiotics.

I have severe diarrhea not caused by an infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NBT-NM108 and irinotecan-based chemotherapy. NBT-NM108 is administered four times daily for 56 days, starting 5 days before chemotherapy.

8 weeks

Regular visits as per chemotherapy schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and tumor response.

6 weeks

Follow-up imaging and assessments

What Are the Treatments Tested in This Trial?

Interventions

• NBT-NM108

Trial Overview The trial is testing NBT-NM108, a high dietary fiber formula designed to reduce chemotherapy-induced diarrhea by supporting gut bacteria health. It aims to improve patients' tolerance of the chemo drug irinotecan, which often causes diarrhea in those treated for advanced colon cancer.

How Is the Trial Designed?

Group I: NM108 Drinks Experimental Treatment 1 Intervention

NBT-NM108 Drinks four times daily before meals and 2 hours after dinner for 56 days. Beginning 5 days before starting chemotherapy, patients receive NBT-NM108 PO QID for 56 days. Patients receive irinotecan-based chemotherapy per standard of care.

Group II: No Microbiome Support Active Control 1 Intervention

No microbiome Patients receive irinotecan-based chemotherapy per standard of care.

Who Is Running the Clinical Trial?

Howard S. Hochster, MD

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

A diet high in dietary fiber, particularly from wheat bran, is associated with a reduced risk of colon cancer, as shown in various studies including case-control and animal models.

Wheat bran specifically inhibits colon tumor development more effectively than other fiber sources like oat and corn bran, and it reduces levels of tumor promoters in the colon, highlighting its potential as a protective dietary component.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of dietary fiber in colon cancer: an overview. Reddy, BS.[2019]

A study involving 29 colorectal cancer survivors demonstrated that increasing the intake of navy beans and rice bran is feasible and can significantly boost dietary fiber levels without causing major gastrointestinal issues.

The increased consumption of these foods showed potential benefits, including improved serum inflammatory biomarkers, suggesting a positive impact on health that warrants further long-term research in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial to Increase Navy Bean or Rice Bran Consumption in Colorectal Cancer Survivors. Borresen, EC., Brown, DG., Harbison, G., et al.[2018]

Sodium butyrate, a metabolite of dietary fiber, effectively reduces colorectal cancer (CRC) burden by targeting the IL-6 receptor gp130 and inhibiting the IL-6/JAK2/STAT3 signaling pathway, as demonstrated through various in vitro and in vivo assays.

The study found that sodium butyrate decreases the levels of the gp130 protein by enhancing its degradation through TRAF5, suggesting a novel mechanism for its anticancer effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fiber metabolite butyrate reduces gp130 by targeting TRAF5 in colorectal cancer cells. Yuan, Y., Li, B., Kuang, Y., et al.[2022]

Populations with higher dietary fiber intake, like those in Umea, Sweden, showed lower fecal secondary bile acid concentrations, which may be protective against colon cancer.

The study suggests that a high fiber diet could reduce colon cancer risk by increasing stool bulk, potentially diluting or binding substances that promote tumors, even in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic epidemiology of colon cancer: dietary pattern and fecal sterol concentrations of three populations. Reddy, BS., Ekelund, G., Bohe, M., et al.[2016]

The Wheat Bran Fiber (WBF) trial is a Phase III clinical study involving 1429 participants aged 40-80, aimed at evaluating the impact of a high WBF diet (13.5 g/day) on the recurrence of colorectal adenomas over a 3-year period.

Participants underwent a 6-week low WBF run-in phase before being randomized, and the study will assess the effectiveness of the intervention through colonoscopies conducted approximately one year after the initial procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and baseline characteristics of study participants in the Wheat Bran Fiber trial. Martínez, ME., Reid, ME., Guillén-Rodríguez, J., et al.[2017]

In a study involving 164 patients with advanced or recurrent stomach cancer, the combination of lentinan (LNT) and the chemotherapy drug tegafur (FT) significantly prolonged survival compared to FT alone, with results showing remarkable lifespan benefits (p < 0.01).

LNT was administered safely with only transitional and non-serious side effects, indicating it is a well-tolerated treatment option for enhancing the efficacy of chemotherapy in stomach cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of lentinan on patients with stomach cancer: end point results of a four-year follow-up survey. Taguchi, T.[2013]

Increasing dietary fiber from wheat bran (WB) from 1% to 8% significantly reduced the incidence of colon tumors in Fischer-344 rats exposed to a carcinogen, indicating a protective effect against colon cancer.

Combining wheat bran with psyllium (PS) resulted in even greater protection against colon tumors than either fiber alone, with a 50:50 mix providing the maximum benefit, suggesting that dietary strategies could help reduce colon cancer risk in high-fat, low-calcium diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential synergism between wheat bran and psyllium: enhanced inhibition of colon cancer. Alabaster, O., Tang, ZC., Frost, A., et al.[2019]

Certain dietary fibers, like wheat bran and pectin, can stimulate cell growth in the large bowel of laboratory rodents, which may be linked to increased risk of colon cancer due to enhanced cell proliferation.

While some fibers promote beneficial fermentation and short-chain fatty acid production, they can also inadvertently increase the likelihood of tumor development, highlighting the need for further research on how different fibers affect colon cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dietary fiber on colonic cell proliferation and its relationship to colon carcinogenesis. Jacobs, LR.[2019]

In a study involving 60 rats, different amounts of dietary fiber (4.8% crude fiber, 20% bran, and no fiber) were tested for their ability to prevent colon cancer induced by a chemical called D.M.H.

After a year of observation, the results showed no significant difference in colon cancer incidence or mortality among the rats treated with D.M.H., regardless of the dietary fiber intake, suggesting that dietary fiber may not have a protective effect against colon cancer in this model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of bran to protect against experimental colon cancer in rats. Cruse, JP., Lewin, MR., Clark, CG.[2019]

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]

Fibersol-2, a soluble dietary fiber recognized as safe, significantly inhibits the growth of human colorectal cancer cells (HCT116) by inducing apoptosis, suggesting potential anti-tumor activity.

In animal studies, Fibersol-2 prevented tumor growth without causing toxicity, and it works by generating reactive oxygen species and activating specific apoptotic pathways, highlighting its potential as a dietary supplement for colorectal cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor suppression by resistant maltodextrin, Fibersol-2. So, EY., Ouchi, M., Cuesta-Sancho, S., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-2-stage-ivb-colon-cancer-ajcc-v8-3-2022-da65d

High Dietary Fiber Formula for Colon Cancer Giving NBT-NM108 to patients with colon cancer receiving chemotherapy may help relieve or lessen diarrhea symptoms and lead to improved tolerance of the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9040862/

Nutritional Modulation of Gut Microbiota Alleviates Severe ... Our study indicates the feasibility of alleviating gastrointestinal symptoms in patients with post-acute COVID-19 syndrome by way of nutritional modulation of ...

3. ichgcp.net ichgcp.net/clinical-trials-registry/NCT04540406

NBT-NM108 and Usual Care Only in Suspected or Confirmed ... This open-label, randomized, and controlled clinical trial aims to determine the feasibility and effectiveness of using NBT-NM108, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12485087/

Harnessing gut microbiota for colorectal cancer therapy The gut microbiota has emerged as a critical player in CRC pathogenesis and a promising therapeutic target to enhance clinical outcomes.

5. research.rutgers.edu research.rutgers.edu/news/new-formula-developed-rutgers-researcher-proves-promising-alleviating-gastrointestinal

New Formula Developed by Rutgers Researcher Proves ... A Rutgers researcher's new formula with Investigational New Drug (IND) status has successfully alleviated a patient's long-term severe gastrointestinal (GI) ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/03/NCT05541003/ICF_002.pdf

Understanding the Role of Gut Microbiota in Hyperphagia ... The purpose of the research is to determine the effectiveness of using an Investigational New Drug. NBT-NM108 to effect the bacteria in the ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/19490976.2025.2457495

Full article: Long COVID and gut microbiome: insights into ... In this review, we highlight the latest evidence on the key microbial alterations observed in PACS, as well as the use of microbiome-based therapeutics in ...