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

Sponsor

Sanguine Biosciences (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05821582

Collaborator

(none)

Enrollment

Location

8.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Other: Stool Collection and Survey Completion

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

8 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 27, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

Primary Objective- Intestinal side effects of chemotherapy [8 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

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*

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanguine Biosciences, Inc.	Woburn	Massachusetts	United States	01801

Sponsors and Collaborators

Sanguine Biosciences

Investigators

Study Director: Andrew C Frisina, M.S., Sanguine Biosciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanguine Biosciences

ClinicalTrials.gov Identifier:

NCT05821582

Other Study ID Numbers:

SAN-09391

First Posted:

Apr 20, 2023

Last Update Posted:

Apr 20, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Apr 20, 2023