Recruiting
Phase 2

Microbiotic Product

Sponsor:

Howard S. Hochster, MD

Code:

NCT05296681

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NBT-NM108

Study Details

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

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

Study ID

NCT05296681

Start date

May 3, 2022

Status verified date

Jan, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

no intervention: No Microbiome Support

No microbiome

Patients receive irinotecan-based chemotherapy per standard of care.

Interventions

NBT-NM108

Patients receive irinotecan-based chemotherapy per standard of care.

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Howard S Hochster, MD

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

Locations

Robert Wood Johnson University Hospital, Hamilton

Recruiting

Hamilton, New Jersey, United States, 08690

Contacts

Howard S Hochster, MD

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

Monmouth Medical Center

Recruiting

Lakewood, New Jersey, United States, 08701

Contacts

Howard Hochster, MD

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

RWJBarnabas Health - Monmouth Medical Center Southern Campus

Recruiting

Lakewood, New Jersey, United States, 08701

Contacts

Howard S. Hochster

732-253-5618howard.hochster@rutgers.edu

Cooperman Barnabas Medical Center

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

Howard S Hochster, MD

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

Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Howard S Hochster, MD

732-235-5912howard.hochster@rutgers.edu

Liping Zhao, MD

(848) 932-5675liping.zhao@rutgers.edu

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Howard S. Hochster

732-253-5618howard.hochster@rutgers.edu

Principal Investigator:

Howard S. Hochster

The Cancer Center

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Howard S Hochster, MD

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

Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Contacts

Howard Hochster, MD

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

Robert Wood Johnson University Hospital, Somerset

Recruiting

Somerville, New Jersey, United States, 08876

Contacts

Howard S Hochster, MD

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

Community Medical Center

Recruiting

Toms River, New Jersey, United States, 08753

Contacts

Howard S Hochster, MD

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

More Information

Sponsor

Howard S. Hochster, MD

Last update posted

Jan 6, 2026

Last verified

Jan, 2026

Keywords

  • chemotherapy-induced diarrhea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Howard S. Hochster, MD on 2026-01-06.