MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Therapy Efficacy: a Multi-omics Pilot Approach. (ITAC)

June 16, 2026 updated by: University Hospital, Bordeaux
This pilot prospective study will investigate the role of microbiota and known enteropathogens in Acute Severe Ulcerative Colitis (ASUC). Investigators will compare a group of patients hospitalized for an ASUC with patients experiencing a Non-Severe Ulcerative Colitis (NSUC) flare by investigating microbiome, metabolome and transcriptome and integrating this data through a multi-omic framework. This systems biology approach aims at enhance our understanding of this severe event, define diagnosis and prognosis biomarkers to improve medical therapy and avoid colectomy and/or death.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ulcerative Colitis (UC) is one of the two entities of Inflammatory Bowel Disease (IBD), along with Crohn's disease. One in 4 patients experiences an Acute Severe Ulcerative Colitis (ASUC) during the disease course, defined as a severe flare with systemic inflammation. ASUC is a medical and surgical emergency as complications and death may occur when patients do not respond to medical therapy and require salvage colectomy. Little is known about the pathophysiology and specifically the triggers of ASUC. At baseline, investigators will investigate the presence of a microbiome signature in patients with an ASUC compared with patients with a non-severe UC flare (NSUC). To identify the role of microorganisms, investigators will look specifically for known enteropathogens, i.e. Clostridium difficile and Cytomegalovirus. Investigators will investigate the impact of microbiota disruptors, such as antibiotics, NSAIDs and diet on microbiota and patients' outcomes. To evaluate the role of the host inflammatory pathways, investigators will study the colonic mucosa transcriptome and the host metabolome, focusing on anti-microbial defence pathways, regarding the suggested role of defective immune defence pathways in IBD pathogenesis. Investigators will focus on the IL23 and Jak pathways, since new drugs targeting these molecules are now available for IBD patients but still not recommended in the ASUC setting. Our last approach will be to evaluate the predictability of the response to therapy according to baseline and early changes of stool microbiome and host metabolome.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Centre Hospitalier Universitaire De Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Patients diagnosed with Ulcerative Colitis according to usual criteria.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute Severe Ulcerative Colitis group
Biological: Blood samples

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.

Procedure: Stool samples

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.

Procedure: Colorectal biopsies
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.
Placebo Comparator: Non-severe Ulcerative Colitis group
Biological: Blood samples

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.

Procedure: Stool samples

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.

Procedure: Colorectal biopsies
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

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2020

Primary Completion (Actual)

November 3, 2021

Study Completion (Actual)

November 3, 2021

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 14, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2019/28
  • 2019-A02462-55 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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