Clinical trial · Observational
Post-Ibrutinib Colitis and Intestinal Microbiota
Identification of Intestinal Microbiota Biomarkers Predictive of Diarrhea in Patients Treated by Ibrutinib.
NCT03569137CI-TRIAL-00033422COLMIunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Identify gut microbiome biomarkers associated with colitis in patients treated with targeted therapy in hematology
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 |
|---|---|---|---|
| Gastrointestinal Microbiome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- difference in microbiome biomarkers between patients developing colitis after exposure to targeted therapy and those not developing colitis
- timeFrame
- At the end of the study, after 2 years.
- description
- With the different species and metabolites between the 2 groups of patients (patients developing diarrhea after exposure to Ibrutinib and those not developing diarrhea), we will create a risk score for occurrence of diarrhea during treatment with Ibrutinib, on the previously developed model (Montassier et al, 2016, Genome medicine)
Secondary outcomes (3)
- measure
- Identify biomarkers of the gut microbiota associated with the occurrence of severe diarrhea (grade 3 and 4 CTCAE, version 4.0) in patients treated with Ibrutinib for malignant hemopathy B.
- timeFrame
- At the end of the study, after 2 years.
- measure
- Identify biomarkers of gut microbiota associated with the occurrence of diarrhea by subgroup: patients treated with Ibrutinib alone, patients treated with Ibrutinib in combination with another molecule
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years * Outside the context of guardianship, -affiliated to the Social Security Regime and * Having consented to participate in the COLMI study. * Patient who benefit of treatment by targeted therapy to Ibrutinib Exclusion Criteria: * History of uncontrolled colitis before the start of treatment. * Patient with inflammatory bowel disease. * Patient not consenting to participate.
References
Publications (0)
Data not yet available
No reference posted for this study.