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High Dietary Fiber Formula for Colon Cancer

Phase 2
Recruiting
Led By Howard Hochster, MD
Research Sponsored by Howard S. Hochster, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Candidate for Second-line or later line therapy with irinotecan-based chemotherapy regimen with starting dose of irinotecan at 180 mg/m2 q2w
No known UGTA1A* genotype
Must not have
Current antibiotic therapy
Grade two diarrhea or greater (4-6 movements per day over baseline)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Summary

This trial is testing whether a high dietary fiber formula can reduce chemotherapy-induced diarrhea in patients with metastatic colon cancer.

Who is the study for?
This trial is for adults with metastatic colon cancer who are set to receive irinotecan-based chemotherapy. They must have a good performance status, meaning they're able to carry out daily activities with little or no assistance. Their blood counts and organ functions need to meet specific criteria, and they shouldn't have had irinotecan or severe diarrhea recently.Check my eligibility
What is being tested?
The trial is testing NBT-NM108, a high dietary fiber formula designed to reduce chemotherapy-induced diarrhea by supporting gut bacteria health. It aims to improve patients' tolerance of the chemo drug irinotecan, which often causes diarrhea in those treated for advanced colon cancer.See study design
What are the potential side effects?
While the side effects of NBT-NM108 aren't detailed here, it's generally expected that high fiber supplements could cause bloating, gas or changes in bowel habits as your body adjusts. The main focus is on reducing severe side effects from chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for a second or later round of chemotherapy that includes irinotecan.
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I don't know my UGTA1A* genotype.
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I can carry out all my usual activities without help.
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My colon cancer has spread and was confirmed by a biopsy.
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I stopped taking irinotecan over 3 months ago and my bowel movements are normal again.
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I am eligible for a specific chemotherapy treatment as my next step.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking antibiotics.
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I experience diarrhea with 4-6 more bowel movements daily than usual.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~eight weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and eight weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Tumor Response by RECIST v1.1 Criteria

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NM108 DrinksExperimental Treatment1 Intervention
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.
Group II: No Microbiome SupportActive Control1 Intervention
No microbiome Patients receive irinotecan-based chemotherapy per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NBT-NM108
2023
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Howard S. Hochster, MDLead Sponsor
Howard Hochster, MDPrincipal InvestigatorRutgers University
2 Previous Clinical Trials
59 Total Patients Enrolled
Howard S Hochster, MDPrincipal InvestigatorRutgers University
1 Previous Clinical Trials
16 Total Patients Enrolled
~12 spots leftby Jul 2025
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