Post-Ibrutinib Colitis and Intestinal Microbiota

• Conditions: Gastrointestinal Microbiome

• Registration Number: NCT03569137
• Lead Sponsor: Nantes University Hospital

Brief Summary

Identify gut microbiome biomarkers associated with colitis in patients treated with targeted therapy in hematology

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-14
• Study First Submitted QC: 2018-06-14
• Last Update Submitted: 2018-06-14
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-26
• Study Start: 2018-08-01
• Primary Completion: 2019-08-01
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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Exclusion Criteria

• History of uncontrolled colitis before the start of treatment.
• Patient with inflammatory bowel disease.
• Patient not consenting to participate.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
difference in microbiome biomarkers between patients developing colitis after exposure to targeted therapy and those not developing colitis	At the end of the study, after 2 years.	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 Outcome Measures

Name	Time	Method
Creation of a predictive score of the occurrence of diarrhea in patients treated with Ibrutinib for malignant hemopathy B, including the biomarkers of the intestinal microbiome and the clinical characteristics of the patient	At the end of the study, after 2 years.
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.	At the end of the study, after 2 years.
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	At the end of the study, after 2 years.

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France