RECRUITING

Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery

Quick Facts

Study Start:2022-05-03
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05296681

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Howard S Hochster, MD
CONTACT
732-235-2465
howard.hochster@rutgers.edu

Principal Investigator

Howard S Hochster, MD
PRINCIPAL_INVESTIGATOR
Rutgers University

Study Locations (Sites)

Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, 08690
United States
Monmouth Medical Center
Lakewood, New Jersey, 08701
United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
The Cancer Center
Newark, New Jersey, 07103
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
Robert Wood Johnson University Hospital, Somerset
Somerville, New Jersey, 08876
United States
Community Medical Center
Toms River, New Jersey, 08753
United States

Collaborators and Investigators

Sponsor: Howard S. Hochster, MD

  • Howard S Hochster, MD, PRINCIPAL_INVESTIGATOR, Rutgers University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-03
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2022-05-03
Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

  • chemotherapy-induced diarrhea

Additional Relevant MeSH Terms

  • 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