Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

• Sponsor: Howard S. Hochster, MD (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05296681
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16.1
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: NBT-NM108	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery
• Anticipated Study Start Date: Apr 30, 2022
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. To Measure Microbiome Health [Two weeks]

   To measure whether the microbiome product, NBT-NM108, can reduce the incidence chemotherapy-induced diarrhea in patients with colon cancer.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903

Sponsors and Collaborators

• Howard S. Hochster, MD

Investigators

• Principal Investigator: Howard Hochster, MD, Rutgers University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Howard S. Hochster, MD, Associate Director for Clinical Research and Director, GI Oncology, Rutgers Cancer Institute, Director of Oncology Research, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT05296681
• Other Study ID Numbers: CINJ 072201
• First Posted: Mar 25, 2022
• Last Update Posted: Apr 21, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Howard S. Hochster, MD, Associate Director for Clinical Research and Director, GI Oncology, Rutgers Cancer Institute, Director of Oncology Research, Rutgers, The State University of New Jersey: chemotherapy-induced diarrhea
• Additional relevant MeSH terms: Colonic Neoplasms

Study Results

No Results Posted as of Apr 21, 2022