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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05821582
• Other study ID #: SAN-09391
• Status: Withdrawn
• Start date: March 27, 2023
• Est. completion date: October 5, 2023

Study information

• Verified date: October 2023
• Source: Sanguine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 5, 2023
• Est. primary completion date: October 5, 2023
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Cohort 1: Colorectal Cancer

Inclusion:

1. The participant is willing and able to provide written informed consent

2. The participant is willing and able to provide appropriate photo identification

3. Participants aged 18 to 85, Inclusive

4. Participants have been diagnosed with Active Colorectal Cancer (CRC)

5. Subjects currently taking irinotecan

Exclusion:

1. Participants who are pregnant or are nursing

2. Participants with a known history of HIV, hepatitis, or other infectious diseases

3. Participants who have taken an investigational product in the last 30 days

4. 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

5. Subjects who are currently in remission for CRC.

• Preference (not required for enrollment into study): Exclude subjects currently taking antibiotics*

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Sanguine Biosciences, Inc.	Woburn	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Sanguine Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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