- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06944873
Metabolic Reprogramming of Monocytes in Inflammatory Flares of Inflammatory Bowel Diseases (REPRO-MICI)
May 18, 2026 updated by: University Hospital, Grenoble
Inflammatory bowel diseases, Crohn's disease and haemorrhagic rectocolitis, are pathologies that progress in flare-ups, impacting on patients' quality of life and functional or even vital prognosis.
These inflammatory diseases require the use of immunosuppressive and immunomodulatory treatments, the side-effects of which can be significant, and the limited number of which sometimes puts patients and practitioners in a therapeutic impasse from which surgery is the only way out.
It is therefore important to be able to develop new therapeutic approaches, ideally better tolerated, that can control inflammation during relapses.
Monocytes are one of the main players in the inflammatory reaction.
In the laboratory, we have developed a strategy for the metabolic reprogramming of these cells based on the use of oxygen microbubbles to modulate the inflammatory response of monocytes.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marianne HUPE, MD PhD
- Phone Number: +33446466912
- Email: mhupe@chu-grenoble.fr
Study Contact Backup
- Name: Anna Borowik, PhD
- Phone Number: +33476769314
- Email: aborowik@chu-grenoble.fr
Study Locations
-
-
-
La Tronche, France, 38700
- Grenoble Alpes University Hospital
-
Contact:
- Marianne HUPE, MD PhD
- Phone Number: +33446466912
- Email: mhupe@chu-grenoble.fr
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with IBD in severe relapse requiring hospitalisation for immunosuppressive therapy or endoscopy for relapse.
Description
Inclusion Criteria:
- Men and women over 18
- Managed at the CHUGA for a severe IBD flare-up requiring hospitalisation or endoscopy for flare-up
- Patient not objecting to the REPRO-MICI study
Exclusion Criteria:
- Patients protected by law (pregnant or breast-feeding women, minors, patients under guardianship or trusteeship, persons deprived of their liberty or hospitalised under duress).
- Patients with positive HIV, HBV or HCV serology.
- Patients with a positive ELISPOT with no history of treatment for latent tuberculosis.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparaison of reduction of concentration of inflammatory cytokines and chemokines in cells treated by oxygen microbubbles vs cells not treated
Time Frame: up to 2 years
|
Validation of inhibition of the production of inflammatory cytokines and chemokines by the monocytes treated by oxygen microbubbles
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparaison of tissue factor expression at the membrane of monocytes treated by microbubbles vs monocytes not treated
Time Frame: up to 2 years
|
Inhibition of tissue factor expression at the membrane of treated monocytes
|
up to 2 years
|
|
Comparaison of glucose metabolism rate in monocytes treated bu microbubbles vs not treated cells
Time Frame: up to 2 years
|
Modulation of glucose metabolism in treated monocytes
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marianne HUPE, MD PhD, Grenoble Alpes University Hospital
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 (Estimated)
July 1, 2026
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
July 31, 2028
Study Registration Dates
First Submitted
January 13, 2025
First Submitted That Met QC Criteria
April 17, 2025
First Posted (Actual)
April 25, 2025
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC24.0363
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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