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RecruitingPhase 2

Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether NBT-NM108, a high-fiber formula, can reduce diarrhea caused by chemotherapy. It is for people with colon cancer that has spread who will receive irinotecan. The formula may help keep gut bacteria healthy and make chemotherapy easier to tolerate.

This phase II trial tests whether NBT-NM108 works in reducing chemotherapy-induced diarrhea in patients with colon cancer that has spread to other places in the body (metastatic). Irinotecan is one of the most used medicine for colon cancer, but it leads to diarrhea in most patients receiving it and among some of them, severe diarrhea can occur. NBT-NM108 is a high dietary fiber formula that is developed based on research findings that have shown that high fiber diets can help maintain healthy bacteria in the gut and improve gut function. Giving NBT-NM108 to patients with colon cancer receiving chemotherapy may help relieve or lessen diarrhea symptoms and lead to improved tolerance of the chemotherapy drug, irinotecan.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have colon cancer confirmed by a biopsy (a tissue sample) that has spread to other parts of the body.
  • Plan to receive chemotherapy with irinotecan after at least one earlier treatment. The starting dose must be 180 mg/m² every 2 weeks.
  • If you took irinotecan before, have stopped it for at least 3 months and have stools back to their usual firmness.
  • Be fully active or able to do light work, with limits only on hard physical activity.
  • Have blood cell counts, kidney tests, liver tests, and blood protein levels that meet the study’s limits.
  • Have no known UGTA1A* gene type, as listed in the study rules.

Who can't join

  • Have moderate or worse diarrhea, such as 4–6 extra bowel movements a day above your usual number. The rules also say people with moderate diarrhea may qualify if stool tests show no infection; the study team should clarify this.
  • Cannot take supplements by mouth.
  • Are currently taking antibiotics.
  • Have a past positive gut or stool test linked to an ongoing infection and diarrhea, unless the infection was fully treated and stools have been normal for at least 3 months.
  • Have a history of ulcerative colitis or Crohn’s disease (diseases that cause swelling in the bowel), or celiac disease (gut damage from gluten).
  • Have long-term swelling of the pancreas, trouble absorbing nutrients, or another digestive disease linked to diarrhea.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria * Biopsy proven and metastatic colon cancer * Candidate for Second-line or later line therapy with irinotecan-based chemotherapy regimen with starting dose of irinotecan at 180 mg/m2 q2w. Participants who have had prior irinotecan will be eligible if they are off irinotecan for at least three months and stools have returned to baseline consistency. * Performance Status (PS) 0-1 * 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 * No known UGTA1A\* genotype Exclusion Criteria * Grade two diarrhea or greater (4-6 movements per day over baseline) * Inability to take oral supplements * Current antibiotic therapy * Baseline grade 3-4 diarrhea Participants with grade two diarrhea should undergo stool evaluation with stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea. They will be eligible if this evaluation shows no infection. * History of the following infections and/or disease which could lead to diarrhea: * History of prior positive gastrointestinal biopsy, gastrointestinal culture, or stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia, Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea unless fully treated with at least three months normal stool. * History of ulcerative colitis, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea.

Study sites (10)

NJ