RecruitingRecruiting
Microbiotic Product to Promote Microbiome Health and Improve Chemotherapy Delivery
NCT05296681 · Rutgers, The State University of New Jersey
In plain English
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Official title
A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 42 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-05-03
Estimated completion: 2027-06-01
Last updated: 2026-01-06
Interventions
Drug: NBT-NM108
Primary outcomes
- • 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 (Eight weeks)
- • Tumor Response by RECIST v1.1 Criteria (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)
Sponsor
Howard S. Hochster, MD · other
Contacts & investigators
ContactHoward S Hochster, MD · contact · howard.hochster@rutgers.edu · 732-235-2465
InvestigatorHoward S Hochster, MD · principal_investigator, Rutgers University
All locations (10)
Robert Wood Johnson University Hospital, HamiltonRecruiting
Hamilton, New Jersey, United States
Monmouth Medical CenterRecruiting
Lakewood, New Jersey, United States
RWJBarnabas Health - Monmouth Medical Center Southern CampusRecruiting
Lakewood, New Jersey, United States
Cooperman Barnabas Medical CenterRecruiting
Livingston, New Jersey, United States
Robert Wood Johnson University HospitalRecruiting
New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
The Cancer CenterRecruiting
Newark, New Jersey, United States
Newark Beth Israel Medical CenterRecruiting
Newark, New Jersey, United States
Robert Wood Johnson University Hospital, SomersetRecruiting
Somerville, New Jersey, United States
Community Medical CenterRecruiting
Toms River, New Jersey, United States