Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens

Study Overview
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Brief Summary
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The primary objective of the study is to determine whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population.

Detailed Description
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STUDY DESIGN: This protocol is a single-center, single-cohort, bioresearch study enrolling up to 8 participants. The cohort is as follows: Cohort 1: Colorectal Cancer: (n=8) The study will enroll participants per the eligibility criteria. Participants will have 2 scheduled at-home stool self-collections at the time points specified in section 4.0 and complete a questionnaire by telephone contact (see section 11.0 for details). The biospecimens collected from participants on this study are stool samples. Confirmation of eligibility and medical record review by a member of the study staff will be completed for participants of the disease cohort before they are considered fully enrolled.

Official Title
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Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Stool Collection and Survey Completion


Participation Criteria
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Eligibility Criteria
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Cohort 1: Colorectal Cancer Inclusion: The participant is willing and able to provide written informed consent The participant is willing and able to provide appropriate photo identification Participants aged 18 to 85, Inclusive Participants have been diagnosed with Active Colorectal Cancer (CRC) Subjects currently taking irinotecan Exclusion: Participants who are pregnant or are nursing Participants with a known history of HIV, hepatitis, or other infectious diseases Participants who have taken an investigational product in the last 30 days Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months Subjects who are currently in remission for CRC. Preference (not required for enrollment into study): Exclude subjects currently taking antibiotics*

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Stool Collection and Survey Completion|Participants will have 2 scheduled at-home stool self-collections at the time points specified in section 4.0 and complete a questionnaire by telephone contact. The biospecimens collected from participants on this study are stool samples.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objective- Intestinal side effects of chemotherapy | The primary objective of the study is to collect stool samples to provide to the sponsor so the sponsor can assess whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population. | 8 months |