Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery
Public ClinicalTrials.gov record NCT05296681. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05296681
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 42 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2, 2022
- Primary completion
- Nov 30, 2026
- Completion
- May 31, 2027
- Last update posted
- Jan 5, 2026
2022 – 2027
United States locations
- U.S. sites
- 10
- U.S. states
- 1
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Robert Wood Johnson University Hospital, Hamilton | Hamilton | New Jersey | 08690 | Recruiting |
| Monmouth Medical Center | Lakewood | New Jersey | 08701 | Recruiting |
| RWJBarnabas Health - Monmouth Medical Center Southern Campus | Lakewood | New Jersey | 08701 | Recruiting |
| Cooperman Barnabas Medical Center | Livingston | New Jersey | 07039 | Recruiting |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | Recruiting |
| The Cancer Center | Newark | New Jersey | 07103 | Recruiting |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | Recruiting |
| Robert Wood Johnson University Hospital, Somerset | Somerville | New Jersey | 08876 | Recruiting |
| Community Medical Center | Toms River | New Jersey | 08753 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05296681, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 5, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05296681 live on ClinicalTrials.gov.