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NBT-NM108 for Chemotherapy-Induced Diarrhea in Metastatic Colon Cancer

This study is testing if NBT-NM108, a high dietary fiber formula, can help reduce diarrhea caused by chemotherapy in people with colon cancer that has spread (metastatic). Irinotecan is a common chemotherapy drug for colon cancer, but it often causes diarrhea. NBT-NM108 is designed to support healthy gut bacteria and improve gut function, which might help lessen diarrhea and allow patients to better tolerate their irinotecan-based chemotherapy. You may be able to join if you have metastatic colon cancer and are starting or continuing irinotecan-based chemotherapy. The study will look at how many participants experience side effects, especially diarrhea, and how well the treatment shrinks tumors. The study is currently recruiting about 42 participants.

Study design
This is an interventional study with a planned enrollment of 42 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Tumor response will be assessed at 6 weeks after treatment, and adverse events will be measured for eight weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05296681

Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

Recruiting
PHASE2Ages 18+InterventionalTreatment
Howard S. Hochster, MD
~42 participants
Updated 2026-01-06 on ClinicalTrials.gov
What's tested:NBT-NM108

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of participants with treatment-related Adverse Events as Assessed by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTCAE) Version 5.0 for toxicity and Adverse Event reporting
Measured over Eight weeks
+1 more outcome measured

Conditions

Metastatic Colon Carcinoma
Stage IV Colon Cancer AJCC v8
Stage IVA Colon Cancer AJCC v8
Stage IVB Colon Cancer AJCC v8
Stage IVC Colon Cancer AJCC v8

Explore related trials

Colon Carcinoma

Where it's being run

10 sites across 1 states
New Jersey10

Study leadership

  • Howard S Hochster, MD · PRINCIPAL_INVESTIGATOR · Rutgers University

Who to contact

Howard S Hochster, MD
[email protected]
732-235-2465
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

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.

What this trial measures

  • The number of participants with treatment-related Adverse Events as Assessed by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTCAE) Version 5.0 for toxicity and Adverse Event reportingEight weeks

    The number of participants with treatment-related Adverse Events as Assessed by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTCAE) Version 5.0 for toxicity and Adverse Event reporting. Dose reduction should occur for CTCAE grade 3 or higher toxicity given maximum antidiarrheal support with Imodium and/or Lomotil.

  • Tumor Response by RECIST v1.1 CriteriaImaging for response assessment will be obtained before the initiation of conditioning (no more than 4 weeks prior to apheresis) and at the 6-week follow up time point

    Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used for tumor measurements