Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

NCT05296681 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 072201Pro2022000222
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

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

Keywords

chemotherapy-induced diarrhea

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

Study Arms (2)

NM108 Drinks

EXPERIMENTAL

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

No Microbiome Support

NO INTERVENTION

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

Interventions

NBT-NM108 DRUG

Patients receive irinotecan-based chemotherapy per standard of care.

NM108 Drinks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Howard S. Hochster, MD: lead

Study Sites (10)

Robert Wood Johnson University Hospital, Hamilton

Hamilton, New Jersey, 08690, United States

RECRUITING

Monmouth Medical Center

Lakewood, New Jersey, 08701, United States

RECRUITING

RWJBarnabas Health - Monmouth Medical Center Southern Campus

Lakewood, New Jersey, 08701, United States

RECRUITING

Cooperman Barnabas Medical Center

Livingston, New Jersey, 07039, United States

RECRUITING

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

The Cancer Center

Newark, New Jersey, 07103, United States

RECRUITING

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

RECRUITING

Robert Wood Johnson University Hospital, Somerset

Somerville, New Jersey, 08876, United States

RECRUITING

Community Medical Center

Toms River, New Jersey, 08753, United States

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Howard S Hochster, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Howard S Hochster, MD

CONTACT

732-235-2465; howard.hochster@rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Director for Clinical Research and Director, GI Oncology, Rutgers Cancer Institute, Director of Oncology Research

Model Details: Participants will be assigned to receive NBT-NM108 or no microbiome support in a 2:1 ratio

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 25, 2022
• Study Start: May 3, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)