- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04272307
MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Therapy Efficacy: a Multi-omics Pilot Approach. (ITAC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Pauline RIVIERE
- Phone Number: +335 57 65 64 39
- Email: pauline.riviere@chu-bordeaux.fr
Study Contact Backup
- Name: Maude CHARBONNIER
- Phone Number: +33557623477
- Email: maude.charbonnier@chu-bordeaux.fr
Study Locations
-
-
-
Bordeaux, France, 33076
- Recruiting
- Centre Hospitalier Universitaire de Bordeaux
-
Contact:
- Pauline RIVIERE
- Phone Number: +335 57 65 64 39
- Email: pauline.riviere@chu-bordeaux.fr
-
Contact:
- Maude CHARBONNIER
- Phone Number: +33557623477
- Email: maude.charbonnier@chu-bordeaux.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
All patients:
- Adult patients diagnosed with Ulcerative Colitis according to usual criteria.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
ASUC group:
Adult patients hospitalized an ASUC defined according to Truelove criteria, i.e. ≥6 bloody daily stools with one or more of the following criteria: temperature >37.8°C, pulse >90 beats/min, haemoglobin <10.5g/dl or C Reactive-Protein >45mg/l.
Non severe acute UC patients (NSUC) group:
Adult patients with disease activity symptoms, corresponding to a partial Mayo score of 4 or more with a rectal bleeding subscore of at least 1, without Truelove severity criteria.
Exclusion Criteria:
- Patients with perianal lesions, ileal lesions or endoscopic aspect of the colonic lesions related to a Crohn's disease acute severe colitis.
- Patients under 18 years old.
- Patients under legal protection or unable to express their consent.
- Patients not affiliated to a health insurance system.
- Patients deprived of liberty by judiciary or administrative decision or hospitalized without consent or admitted in a sanitary or social institution for another reason than research
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Acute Severe Ulcerative Colitis group
|
At inclusion, at day 5, day 42 and at 3 months, one 2 ml EDTA blood tube will be collected for metabolomics. Polar metabolites, lipids, free fatty acids and bile acids will be identified and quantitated using ultra high-performance liquid chromatography/tandem accurate mass spectrometry method. At inclusion, one 2 ml EDTA tube will be stored as a DNA collection. One stool sample will be taken at baseline, day 5, day 42 and at 3 months and frozen at -80°C and divided in 2 aliquots. One stool aliquot will be used for metabolomics. Polar metabolites, lipids, free fatty acids and bile acids will be identified and quantitated using ultra high-performance liquid chromatography/tandem accurate mass spectrometry method. The other one will be used for microbiota analysis. Samples will be sent to the McGill University (Prof. SALEH's lab) for extraction and then, Génome Québec Innovation Centre (McGill University, Montréal, Canada) for sequencing of the V4 region of the 16S rRNA gene on Illumina MiSeq in paired-end mode.
During routine flexible sigmoidoscopy, 6 biopsies will be collected with a 5 mm biopsy forceps at baseline and at 3 months.
Biopsies will be placed into a sterile vial containing RNAlater (Qiagen, Hilden, Germany) and stored at -80°C.
Two biopsies will be used for mucosal microbiome analysis in the same way as the stool sample.
Four biopsies will be used for RNAseq.
Samples will be shipped to Prof. SALEH's lab in Montréal for nucleic acid extraction.
The McGill University and Génome Québec Innovation Centre (McGill University, Montréal, Canada) will provide library preparation and next generation sequencing.
The average number of uniquely mapped reads per sequencing run will be 30 million reads per sample.
|
Non-severe Ulcerative Colitis group
|
At inclusion, at day 5, day 42 and at 3 months, one 2 ml EDTA blood tube will be collected for metabolomics. Polar metabolites, lipids, free fatty acids and bile acids will be identified and quantitated using ultra high-performance liquid chromatography/tandem accurate mass spectrometry method. At inclusion, one 2 ml EDTA tube will be stored as a DNA collection. One stool sample will be taken at baseline, day 5, day 42 and at 3 months and frozen at -80°C and divided in 2 aliquots. One stool aliquot will be used for metabolomics. Polar metabolites, lipids, free fatty acids and bile acids will be identified and quantitated using ultra high-performance liquid chromatography/tandem accurate mass spectrometry method. The other one will be used for microbiota analysis. Samples will be sent to the McGill University (Prof. SALEH's lab) for extraction and then, Génome Québec Innovation Centre (McGill University, Montréal, Canada) for sequencing of the V4 region of the 16S rRNA gene on Illumina MiSeq in paired-end mode.
During routine flexible sigmoidoscopy, 6 biopsies will be collected with a 5 mm biopsy forceps at baseline and at 3 months.
Biopsies will be placed into a sterile vial containing RNAlater (Qiagen, Hilden, Germany) and stored at -80°C.
Two biopsies will be used for mucosal microbiome analysis in the same way as the stool sample.
Four biopsies will be used for RNAseq.
Samples will be shipped to Prof. SALEH's lab in Montréal for nucleic acid extraction.
The McGill University and Génome Québec Innovation Centre (McGill University, Montréal, Canada) will provide library preparation and next generation sequencing.
The average number of uniquely mapped reads per sequencing run will be 30 million reads per sample.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of the faecal microbiota in each group.
Time Frame: Inclusion Visit
|
Sequencing of the V4 region of the 16S rRNA gene at inclusion on the colonic biopsies taken during routine sigmoidoscopy.
|
Inclusion Visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of Clostridium difficile infections
Time Frame: Inclusion Visit
|
Investigators will define a Clostridium difficile infection as Glutamate dehydrogenase positive test associated to Polymerase Chain Reaction Toxin positive test in the stool or intestinal fluid.
|
Inclusion Visit
|
Diagnosis of Cytomegalovirus (CMV) infections
Time Frame: baseline
|
Investigators will define a CMV infection as presence of CMV inclusions in Hemalum Eosine or ImmunoHistoChemistry in the colonic biopsies taken during the baseline sigmoidoscopy
|
baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2019/28
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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