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

NCT05171452 | Completed

• 2 other identifiers: APHP1804502018-A02342-53
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Inflammatory bowel diseases; urinary marker

Outcome Measures

Primary Outcomes (1)

• Correlation between urinary PGE-MUM and fecal Calprotectin concentrations

  A statistical analysis will allow to evaluate the correlation and bias between urinary PGE-MUM concentration in mg/g-creatinine and fecal calprotectin concentration in patients with chronic inflammatory bowel disease (IBD). To compare the urinary PGE-MUM level equivalence according to predetermined calprotectin values recognized as biological cut-points, e.g. Calprotectin \<50μg /g-stool is considered normal; \> 250μg /g-stool is considered active inflammation.

  12 months

Secondary Outcomes (1)

• Correlation between urinary PGE-MUM and serum CRP concentrations

  12 months

Study Arms (2)

Group A: Adult IBD with active inflammation

Biological: Urine and stoll samples

Group B: Adult IBD in remission

Biological: Urine and stoll samples

Interventions

Urine and stoll samples BIOLOGICAL

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)

Group A: Adult IBD with active inflammation; Group B: Adult IBD in remission

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults with inflammatory bowel disease (IBD or UC) consulting, for the follow-up of their chronic disease, the gastroenterology department of Beaujon Hospital.

You may qualify if:

• Patients aged 18 to 60 years
• Patients with chronic inflammatory bowel disease, IBD (Crohn's or Ulcerative colitis)
• Patients with active or inactive disease (remission)
• Patients treated as part of their routine care and required to undergo a routine blood test, fecal tests and endoscopic examination, if applicable
• Patients covered by the social security scheme and / or professional health insurance
• Patients giving their free and informed consent after information

You may not qualify if:

• Patients who have been deemed unfit to participate in the study by the attending physician
• Patients under 18 years
• Patients who have undergone colorectal surgery with complete resection or who have undergone intestinal resection surgery within six months
• Patients taking irritating laxatives, nonsteroidal anti-inflammatory drugs (NSAIDs) and drug formulations containing prostaglandins at the time of urine collection

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de biochimie clinique - Hôpital Beaujon

Clichy, 92110, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine and stool samples

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Urination

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 29, 2021
• Study Start: October 3, 2019
• Primary Completion: October 19, 2020
• Study Completion: October 19, 2020
• Last Updated: December 29, 2021

Record last verified: 2021-11

Locations

FR (1)