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Urinary PGE-MUM (PROSTAGLANDIN E-MAJOR URINARY METABOLITE) as Inflammatory Marker in Chronic Inflammatory Bowel Disease

NCT05171452 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2021-12-29

No results posted yet for this study

Summary

The inflammatory bowel diseases (IBD) are lifelong, relapsing-remitting diseases. As the timing of relapse is unpredictable, and current monitoring is symptoms-based, there remains a window between the initial upregulation of the inflammatory response and the onset of clinical symptoms at which point the inflammatory episode is well established. The use of endoscopy as means of predicting relapse is not suitable for regular use. The potential role of Fecal calprotectin (FC) in IBD in predicating the risk of relapse has been well investigated with key studies. Its fecal concentration is proportional to neutrophilic influx into the intestinal tract, which is a feature of active IBD. FC correlates well with the severity of endoscopic lesions. After excretion, FC remains stable in the feces for 1 week at room temperature. However, its considerable daily variation suggests interfering factors discrete from inflammatory disease. There is increasing research into novel markers with high correlation to the presence of mucosal healing constitute a cost-effective substitute to repeated endoscopies. Recent studies have reported that the prostaglandin E-major urinary metabolite (PGE-MUM) level was significantly higher in the active phase of patients with ulcerative disease (UC) than those in the remission phase. In the active UC phase, the stimulation of inflammatory cytokines, such as tumor necrosis factor-α, leads to the upregulation of cyclooxygenase-2 (COX-2) leading to PGE2 secretion in mucosal tissue. PGE2 plays an important role in the progression of inflammation. A precise measure of serum PGE2 is difficult due to the short half-life of PGE2 in the blood. Conversely, the urinary metabolite of prostaglandin E-major (PGE-MUM, 7-hydroxy-5,11-diketotetranor-prosta-1,16-dioic acid) is stable and may reflects the histological severity of inflammation. The aim of this concept study is to evaluate the PGE-MUM concentration in urine of patients with IBD in parallel with the standard investigation of Calprotectin in stool and to assess if urinary PGE-MUM should be able to serve as a simple and robust substitutive biomarker for the non-invasive evaluation of the inflammation of the mucous membrane tissues. The measurement of PGE-MUM in urine could give patients with IBD more comfort than the measurement of calprotectin in stool.

Conditions

  • Inflammatory Bowel Diseases

Interventions

BIOLOGICAL

Urine and stoll samples

Urine collection will be proposed to patient during consultations or medical examinations corresponding to routine care of patients with IBD at the time of prescribing a FC test. The urine sample, as for stool samples, will be collected in an ordinary universal container at any time of the day (no dietary restriction is required). Urine and stool samples should be taken during the same period (for example, the same day, or within a maximum of one week if no change in treatment)

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-03
Primary Completion
2020-10-19
Completion
2020-10-19

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05171452 on ClinicalTrials.gov