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WithdrawnNCT05821582Updated Oct 12, 2023

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

An observational study in Colorectal Cancer, sponsored by Sanguine Biosciences. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-10-12.

Sponsored by Sanguine Biosciences · Observational

Why this study was withdrawn
Insufficient recruitment population.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

Browse Colorectal Neoplasms studies →

Lead sponsor

Sanguine Biosciences is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients with active colorectal cancer

Cohort 1: Colorectal Cancer

Inclusion criteria

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 criteria

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*
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • OtherStool 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 months

07

Study locations

1 site
  • Sanguine Biosciences, Inc.
    Woburn, Massachusetts 01801, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05821582
Lead sponsor
Sanguine Biosciences
Responsible party
Sponsor
First posted
Apr 20, 2023
Start date
Mar 27, 2023
Primary completion
Oct 5, 2023
Completion
Oct 5, 2023
Last update
Oct 12, 2023

Study contacts

Andrew C Frisina, M.S.
study director · Sanguine Biosciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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