Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

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 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NBT-NM108 — DRUG
  Patients receive irinotecan-based chemotherapy per standard of care.

Study Details

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.

Key Dates

Start date

May 3, 2022

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Jun 1, 2027

Study Design

Enrollment

42 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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 ]

Central Contacts

• Howard S Hochster, MD
  732-235-2465
  [email protected]

Locations (10)

Find similar trials in Hamilton, NJ

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