Clinical trial · Observational
Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens
NCT05821582CI-TRIAL-00070421withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient recruitment population.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stool Collection and Survey Completion | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Primary Objective- Intestinal side effects of chemotherapy
- timeFrame
- 8 months
- description
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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\*
References
Publications (0)
Data not yet available
No reference posted for this study.