Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

January 4, 2026 updated by: Howard S. Hochster, MD

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY ENDPOINT:

Dose Intensity of Irinotecan administered (mg/m2/week)

SECONDARY ENDPOINTS:

  1. Reduction in % Patients Needing Dose Modification for Diarrhea
  2. Toxicity Grade of diarrhea
  3. Response Rate
  4. Time to Progression-free survival

EXPLORATORY ENDPOINTS:

  1. 16S rRNA gene sequencing to reveal changes of the gut microbiota including institution of foundation guilds and restoration of healthy microbiome
  2. Short chain fatty acids analysis (promotion of acetic and butyric acid production)
  3. Markers for gut inflammation such as fecal lipocalin 2
  4. Gut barrier function test to see if the restoration of healthier gut microbiota would improve gut barrier function.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Hamilton, New Jersey, United States, 08690
        • Recruiting
        • Robert Wood Johnson University Hospital, Hamilton
        • Contact:
      • Lakewood, New Jersey, United States, 08701
        • Recruiting
        • RWJBarnabas Health - Monmouth Medical Center Southern Campus
        • Contact:
      • Lakewood, New Jersey, United States, 08701
      • Livingston, New Jersey, United States, 07039
        • Recruiting
        • Cooperman Barnabas Medical Center
        • Contact:
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
        • Principal Investigator:
          • Howard S. Hochster
      • New Brunswick, New Jersey, United States, 08901
      • Newark, New Jersey, United States, 07112
        • Recruiting
        • Newark Beth Israel Medical Center
        • Contact:
      • Newark, New Jersey, United States, 07103
      • Somerville, New Jersey, United States, 08876
        • Recruiting
        • Robert Wood Johnson University Hospital, Somerset
        • Contact:
      • Toms River, New Jersey, United States, 08753

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NM108 Drinks

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.
Drug: NBT-NM108
Patients receive irinotecan-based chemotherapy per standard of care.
No Intervention: No Microbiome Support

No microbiome

Patients receive irinotecan-based chemotherapy per standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Eight 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.
Eight weeks
Tumor Response by RECIST v1.1 Criteria
Time Frame: Imaging 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
Imaging 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Howard S. Hochster, MD

Investigators

  • Principal Investigator: Howard S Hochster, MD, Rutgers University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 16, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Estimated)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 072201
  • Pro2022000222 (Other Identifier: Rutgers, The State University of New Jersey)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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