External Validation of a Microscopic Colitis Clinical Scoring System in Patients With Chronic Watery Diarrhoea

NCT06031064 | Unknown

• 1 other identifier: P/22-108
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic watery diarrhoea is a very common problem in the population and most of these patients will be referred for colonoscopy. If no macroscopic findings are observed during colonoscopy to justify the diarrhoea, serial colonic biopsies will be taken to rule out Microscopic Colitis (MC). However, it has been estimated that only 10-15% of these patients will be diagnosed with MC after colonoscopy. Therefore, about 80% of the biopsies collected and analysed will not be useful to establish a diagnosis, considerably increasing costs. To predict the risk of developing MC, a new promising clinical scoring system has been recently developed. This score will be useful in the diagnostic work-up of chronic watery diarrhoea to prioritize colonoscopy with stepwise colonic biopsies in patients with a positive highly specific score for MC. In cases with a negative score, colonoscopy plus biopsies should be performed only if other diagnostic tests are negative. The aim of this current study is to externally validate the new scoring system to predict MC in patients with chronic watery diarrhoea.

Conditions

Microscopic Colitis

Keywords

Inflammatory bowel disease (IBD); clinical scoring; chronic watery diarrhea

Outcome Measures

Primary Outcomes (1)

• Percentage of patients diagnosed with Microscopic Colitis (MC)

  MC diagnosis based on clinical and histological criteria as established by the European guidelines on microscopic colitis: Miehlke S, Guagnozzi D, Zabana Y, et al. European guidelines on microscopic colitis: United European Gastroenterology and European Microscopic Colitis Group statements and recommendations \[published online ahead of print, 2021 Feb 22\]. United European Gastroenterol J. 2021;9(1):13-37

  up to 2 months (after clinical and histological assessment)

Secondary Outcomes (1)

• Faecal calprotectin concentration (μg/g)

  at inclusion (prior to colonoscopy)

Study Arms (1)

Patients with chronic watery diarrhoea and clinical suspicion of MC

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients derived at the digestive system department with chronic watery diarrhoea and clinical suspicion of MC, requiring colonoscopy with biopsies to complete the study

You may qualify if:

• Age 40 years or older.
• Patient with chronic non-bloody watery diarrhoea (Bristol scale=6 or 7), with 2 or more liquid stools per day, of frequent occurrence (at least 3 times per week), of at least 1 month's duration.
• Normal blood test and biochemistry (including C reactive protein and TSH), negative anti-transglutaminase antibodies, and negative faecal ova and parasites. A 75SeHCAT is not mandatory.
• Patients with an indication for a diagnostic colonoscopy by their physician at charge, mainly to rule out MC.
• Signature of the study informed consent

You may not qualify if:

• Patients with either alternating diarrhoea-constipation or self-limiting diarrhoea at the time of colonoscopy.
• History of inflammatory bowel disease or coeliac disease, bile acid diarrhoea.
• Previous gastrointestinal surgery (excluding appendectomy or inguinal herniorrhaphy).
• Incomplete colonoscopy or no colon biopsies of at least right and left colon in separate containers (minimum 2 samples of each segment).
• Unsatisfactory preparation for a complete exploration (Boston scale \<6, any segment \<2)
• Significant macroscopic lesions on colonoscopy, other than those occasionally described in MC
• Inability to understand the instructions for participating in the study.

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead

Study Sites (1)

Hospital Universitari MútuaTerrassa

Terrassa, Barcelona, 08221, Spain

RECRUITING

Related Publications (17)

• Miehlke S, Guagnozzi D, Zabana Y, Tontini GE, Kanstrup Fiehn AM, Wildt S, Bohr J, Bonderup O, Bouma G, D'Amato M, Heiberg Engel PJ, Fernandez-Banares F, Macaigne G, Hjortswang H, Hultgren-Hornquist E, Koulaouzidis A, Kupcinskas J, Landolfi S, Latella G, Lucendo A, Lyutakov I, Madisch A, Magro F, Marlicz W, Mihaly E, Munck LK, Ostvik AE, Patai AV, Penchev P, Skonieczna-Zydecka K, Verhaegh B, Munch A. European guidelines on microscopic colitis: United European Gastroenterology and European Microscopic Colitis Group statements and recommendations. United European Gastroenterol J. 2021 Feb 22;9(1):13-37. doi: 10.1177/2050640620951905. Online ahead of print.

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Biospecimen

Retention: SAMPLES WITH DNA

Frozen colon tissue and faecal sample

MeSH Terms

Conditions

Colitis, Microscopic; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Yamile Zabana, MD, PhD

CONTACT

yzabana@gmail.com

Study Design

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

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 11, 2023
• Study Start: May 15, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: September 11, 2023

Record last verified: 2023-08

Locations

ES (1)