Inflammatory Bowel DiseasesEarly Phase 1ITACNCT04272307
MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Therapy Efficacy: a Multi-omics Pilot Approach.
A Early Phase 1 study testing Blood samples, Stool samples and Colorectal biopsies in people with Inflammatory Bowel Diseases and Colitis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Colitis, Ulcerative
- What is being tested?
- Blood samples, Stool samples and Colorectal biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2020to 3 Nov 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative
- Being tested
- Blood samples, Stool samples, Colorectal biopsies
- Keywords
- Inflammatory Bowel Disease, Acute severe ulcerative colitis, Microbiome, Prognostic factors
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
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.
Stool samplesProcedure or surgery
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.
Colorectal biopsiesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute Severe Ulcerative Colitis group | Experimental | Not described Receives: Biological: Blood samples; Procedure: Stool samples; Procedure: Colorectal biopsies |
| Non-severe Ulcerative Colitis group | Placebo comparator | Not described Receives: Biological: Blood samples; Procedure: Stool samples; Procedure: Colorectal biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the faecal microbiota in each group.
Sequencing of the V4 region of the 16S rRNA gene at inclusion on the colonic biopsies taken during routine sigmoidoscopy.
Measured: Inclusion Visit
Secondary outcomes (2)
Diagnosis of Clostridium difficile infections
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.
Measured: Inclusion Visit
Diagnosis of Cytomegalovirus (CMV) infections
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start14 May 2020
- Primary completion3 Nov 2021
- Study completion3 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272307
- Sponsor's protocol ID
- CHUBX 2019/28
- Other IDs
- 2019-A02462-55
- Acronym
- ITAC
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riviere P, Le Chevillier A, Rullier A, Marty M, Schurr E, Lapuyade B, Celerier B, Fernandez B, Bessissow T, Treton X, Uzzan M, Poullenot F, Berger A, Zerbib F, Laharie D. Deep ulcers are associated with increased C-reactive protein in active ulcerative colitis. Dig Liver Dis. 2023 Sep;55(9):1194-1200. doi: 10.1016/j.dld.2023.05.004. Epub 2023 May 25.
PubMed 37244790
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIcroorganisms as Triggers in Acute Severe Ulcerative Colitis and Their Influence on Medical Therapy Efficacy: a Multi-omics Pilot Approach.
- ClinicalTrials.gov ID
- NCT04272307
- Acronym / sponsor ID
- ITAC / CHUBX 2019/28
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative
- Keywords
- Inflammatory Bowel Disease, Acute severe ulcerative colitis, Microbiome, Prognostic factors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 14 May 2020 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Severe Ulcerative Colitis group | Experimental | Biological: Blood samples, Procedure: Stool samples, Procedure: Colorectal biopsies |
| Non-severe Ulcerative Colitis group | Placebo comparator | Biological: Blood samples, Procedure: Stool samples, Procedure: Colorectal biopsies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
- 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.
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesAt 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. | Biological | Acute Severe Ulcerative Colitis group, Non-severe Ulcerative Colitis group |
| Stool samplesOne 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 or surgery | Acute Severe Ulcerative Colitis group, Non-severe Ulcerative Colitis group |
| Colorectal biopsiesDuring 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. | Procedure or surgery | Acute Severe Ulcerative Colitis group, Non-severe Ulcerative Colitis group |
Primary outcome
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.
2 secondary outcomes
Diagnosis of Clostridium difficile infections
Time frame: Inclusion Visit
Diagnosis of Cytomegalovirus (CMV) infections
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Results publication: PubMed 37244790Riviere P, Le Chevillier A, Rullier A, Marty M, Schurr E, Lapuyade B, Celerier B, Fernandez B, Bessissow T, Treton X, Uzzan M, Poullenot F, Berger A, Zerbib F, Laharie D. Deep ulcers are associated with increased C-reactive protein in active ulcerative colitis. Dig Liver Dis. 2023 Sep;55(9):1194-1200. doi: 10.1016/j.dld.2023.05.004. Epub 2023 May 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Blood samples, Stool samples and Colorectal biopsies in people with Inflammatory Bowel Diseases and Colitis, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the faecal microbiota in each group. (time frame: Inclusion Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04272307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.