NCT06944873

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
24mo left

Started Jul 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Jul 2028

First Submitted

Initial submission to the registry

January 13, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

January 13, 2025

Last Update Submit

May 18, 2026

Conditions

Keywords

MonocytesMetabolic reprogramming

Outcome Measures

Primary Outcomes (1)

  • Comparaison of reduction of concentration of inflammatory cytokines and chemokines in cells treated by oxygen microbubbles vs cells not treated

    Validation of inhibition of the production of inflammatory cytokines and chemokines by the monocytes treated by oxygen microbubbles

    up to 2 years

Secondary Outcomes (2)

  • Comparaison of tissue factor expression at the membrane of monocytes treated by microbubbles vs monocytes not treated

    up to 2 years

  • Comparaison of glucose metabolism rate in monocytes treated bu microbubbles vs not treated cells

    up to 2 years

Interventions

Blood test 4 EDTA tubes for biological check-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with IBD in severe relapse requiring hospitalisation for immunosuppressive therapy or endoscopy for relapse.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble Alpes University Hospital

La Tronche, 38700, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Marianne HUPE, MD PhD

    Grenoble Alpes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne HUPE, MD PhD

CONTACT

Anna Borowik, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

April 25, 2025

Study Start

July 1, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations