Validation of a scoring system for diagnosing Microscopic Colitis in patients with chronic diarrhea
External Validation of a Clinical Scoring System to Predict Microscopic Colitis in Patients With Chronic Watery Diarrhoea
This study is testing a new scoring system to help doctors figure out if people with chronic diarrhea might have Microscopic Colitis and if they need further testing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Hospital Mutua de Terrassa Academic / other |
| Locations | 1 site (Terrassa, Barcelona) |
| Trial ID | NCT06031064 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a clinical scoring system designed to predict the risk of Microscopic Colitis (MC) in patients experiencing chronic watery diarrhea. It will assess two existing scoring systems, the Kane and Cotter scores, which utilize various risk factors to identify patients who may benefit from colonoscopy and biopsies. Additionally, the study will explore the inclusion of fecal calprotectin levels to enhance diagnostic accuracy. By refining the diagnostic process, the study seeks to reduce unnecessary procedures and associated costs.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 40 years or older with chronic non-bloody watery diarrhea lasting at least one month.
Not a fit: Patients with alternating diarrhea-constipation or self-limiting diarrhea, as well as those with a history of inflammatory bowel disease or coeliac disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of Microscopic Colitis, reducing unnecessary colonoscopies and improving patient management.
How similar studies have performed: While the scoring systems have been derived from retrospective studies, this prospective validation could provide new insights into their effectiveness, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Terrassa, Barcelona
- Hospital Universitari MútuaTerrassa — Terrassa, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Yamile Zabana, MD, PhD
- Email: yzabana@gmail.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.