Microscopic ColitisNCT06031064
External Validation of a Microscopic Colitis Clinical Scoring System in Patients With Chronic Watery Diarrhoea
An observational study of Microscopic Colitis, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Microscopic Colitis
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2022to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Yamile Zabana, MD, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari MútuaTerrassa
Terrassa, Barcelona, 08221
About this study
Official title: External Validation of a Clinical Scoring System to Predict Microscopic Colitis in Patients With Chronic Watery Diarrhoea
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.
Read the detailed description
Two diagnostic scoring systems have been proposed to predict the risk of developing MC: 1) The Kane score (sensitivity (SN) 96%; specificity (SP) 46%) combines eight risk factors, including female sex, age over 50 years, weight loss, absence of abdominal pain, and use of proton pump inhibitors (PPIs) and non-steroidal anti-inflammatory drugs (NSAIDs), presence of nocturnal diarrhoea and diarrhoea duration of less than 6 months. 2) The Cotter score (SN 93%; SP 49%) includes age ≥55 years, duration of diarrhoea ≤6 months, ≥5 bowel movements per day, body mass index <30 kg/m2, current smoking, and current use of selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors and NSAIDs. However, both scoring systems have been derived from retrospective studies and watery chronic diarrhoea, the hallmark clinical symptom of MC, was not well defined.
Besides MC risk factors, faecal markers could also be useful for MC screening. Most studies have found that 60-75% of the patients with active collagenous colitis, a subtype of MC, have elevated faecal calprotectin levels. Moreover, a recent study showed that faecal calprotectin concentrations >100 μg/g (AUC, 0.73) showed a 67% sensitivity and 75% specificity to predict MC.
To further assess the value of the Kane and Cotter scoring systems and to derive a new score including faecal calprotectin aiming to increase specificity, the investigators performed a prospective observational two-centres study. Chronic watery diarrhoea was defined as ≥2 watery stools (Bristol 6-7) per day, of frequent occurrence (≥3 times per week), of at least 1 month duration. A registry of demographic and clinical characteristics (VAS of 0-100 of abdominal pain and abdominal distension, presence of nocturnal diarrhoea, urgency and faecal incontinence, smoking, body mass index, weight loss, use of drugs) was performed. The study included 118 patients with chronic watery diarrhoea, from which 41 were diagnosed with MC (21 lymphocytic colitis, 16 collagenous colitis and 4 paucicellular colitis) and obtained lower SN and SP values than those published of the Cotter (SN 78%; SP 57%) and Kane (SN 78%; SP 38%) scores. The AUC of both scores was 0.71 and 0.66, respectively. The multivariate analysis identified 5 variables associated with MC: >5 stools/day (OR 12.5), duration of diarrhoea ≤8 months (OR 5), regular use of low-dose acetylsalicylic acid (ASA) (OR 4), BMI ≤26 Kg/m2 (OR 4.1) and faecal calprotectin >500 µg/g (OR 5.5). A new score was developed using the variables mentioned above with an AUC of 0.86 (p<0.001 vs. Kane and Cotter scores). A score >10 had a sensitivity of 61.5% and a specificity of 92%. A score >17 gave a specificity of 100% with a sensitivity of 36%. The score was internally validated using bootstrapping techniques.
Although promising, the new scoring system must be externally validated before generalizing its use in clinical practice.
- Conditions
- Microscopic Colitis
- Keywords
- Inflammatory bowel disease (IBD), clinical scoring, chronic watery diarrhea
- Medical subject headings
- Colitis, Microscopic, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic watery diarrhoea and clinical suspicion of MC | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 2 months (after clinical and histological assessment)
Secondary outcomes (1)
Faecal calprotectin concentration (μg/g)
Faecal calprotectin concentration (μg/g) will be measured using a DSX system analyser (Dynex technologies, Worthing, UK) by ELISA (BÜHLMANN fCAL, Schönenbuch, Switzerland or similar)
Measured: at inclusion (prior to colonoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start15 May 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Microscopic ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031064
- Sponsor's protocol ID
- P/22-108
- Status last verified
- Aug 2023
- First submitted
- 28 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33619914Beaugerie L, Pardi DS. Review article: drug-induced microscopic colitis - proposal for a scoring system and review of the literature. Aliment Pharmacol Ther. 2005 Aug 15;22(4):277-84. doi: 10.1111/j.1365-2036.2005.02561.x.
PubMed 16097993Larsson JK, Sjoberg K, Vigren L, Benoni C, Toth E, Olesen M. Chronic non-bloody diarrhoea: a prospective study in Malmo, Sweden, with focus on microscopic colitis. BMC Res Notes. 2014 Apr 14;7:236. doi: 10.1186/1756-0500-7-236.
PubMed 24731750Fernandez-Banares F, de Sousa MR, Salas A, Beltran B, Piqueras M, Iglesias E, Gisbert JP, Lobo B, Puig-Divi V, Garcia-Planella E, Ordas I, Andreu M, Calvo M, Montoro M, Esteve M, Viver JM; RECOMINA Project, GETECCU Grupo Espanol de Enfermedades de Crohn y Colitis Ulcerosa. Epidemiological risk factors in microscopic colitis: a prospective case-control study. Inflamm Bowel Dis. 2013 Feb;19(2):411-7. doi: 10.1002/ibd.23009.
PubMed 23344243Kane JS, Rotimi O, Everett SM, Samji S, Michelotti F, Ford AC. Development and validation of a scoring system to identify patients with microscopic colitis. Clin Gastroenterol Hepatol. 2015 Jun;13(6):1125-31. doi: 10.1016/j.cgh.2014.12.035. Epub 2015 Jan 20.
PubMed 25616029Kane JS, Sood R, Law GR, Gracie DJ, To N, Gold MJ, Ford AC. Validation and modification of a diagnostic scoring system to predict microscopic colitis. Scand J Gastroenterol. 2016 Oct;51(10):1206-12. doi: 10.1080/00365521.2016.1186221. Epub 2016 May 31.
PubMed 27243102Cotter TG, Binder M, Harper EP, Smyrk TC, Pardi DS. Optimization of a Scoring System to Predict Microscopic Colitis in a Cohort of Patients With Chronic Diarrhea. J Clin Gastroenterol. 2017 Mar;51(3):228-234. doi: 10.1097/MCG.0000000000000565.
PubMed 27404403Fernandez-Banares F, Casanova MJ, Arguedas Y, Beltran B, Busquets D, Fernandez JM, Fernandez-Salazar L, Garcia-Planella E, Guagnozzi D, Lucendo AJ, Mancenido N, Marin-Jimenez I, Montoro M, Piqueras M, Robles V, Ruiz-Cerulla A, Gisbert JP; Spanish Microscopic Colitis Group (SMCG). Current concepts on microscopic colitis: evidence-based statements and recommendations of the Spanish Microscopic Colitis Group. Aliment Pharmacol Ther. 2016 Feb;43(3):400-26. doi: 10.1111/apt.13477. Epub 2015 Nov 24.
PubMed 26597122Limburg PJ, Ahlquist DA, Sandborn WJ, Mahoney DW, Devens ME, Harrington JJ, Zinsmeister AR. Fecal calprotectin levels predict colorectal inflammation among patients with chronic diarrhea referred for colonoscopy. Am J Gastroenterol. 2000 Oct;95(10):2831-7. doi: 10.1111/j.1572-0241.2000.03194.x.
PubMed 11051356Wildt S, Nordgaard-Lassen I, Bendtsen F, Rumessen JJ. Metabolic and inflammatory faecal markers in collagenous colitis. Eur J Gastroenterol Hepatol. 2007 Jul;19(7):567-74. doi: 10.1097/MEG.0b013e328058ed76.
PubMed 17556903Wagner M, Peterson CG, Stolt I, Sangfelt P, Agnarsdottir M, Lampinen M, Carlson M. Fecal eosinophil cationic protein as a marker of active disease and treatment outcome in collagenous colitis: a pilot study. Scand J Gastroenterol. 2011 Jul;46(7-8):849-54. doi: 10.3109/00365521.2011.571707. Epub 2011 May 11.
PubMed 21557718Stoicescu A, Becheanu G, Dumbrava M, Gheorghe C, Diculescu M. Microscopic colitis - a missed diagnosis in diarrhea-predominant irritable bowel syndrome. Maedica (Bucur). 2012 Jan;7(1):3-9.
PubMed 23118812Batista L, Ruiz L, Ferrer C, Zabana Y, Aceituno M, Arau B, Andujar X, Esteve M, Fernandez-Banares F. Usefulness of fecal calprotectin as a biomarker of microscopic colitis in a cohort of patients with chronic watery diarrhoea of functional characteristics. Dig Liver Dis. 2019 Dec;51(12):1646-1651. doi: 10.1016/j.dld.2019.07.002. Epub 2019 Aug 2.
PubMed 31383457Palsson OS, Whitehead W, Tornblom H, Sperber AD, Simren M. Prevalence of Rome IV Functional Bowel Disorders Among Adults in the United States, Canada, and the United Kingdom. Gastroenterology. 2020 Apr;158(5):1262-1273.e3. doi: 10.1053/j.gastro.2019.12.021. Epub 2020 Jan 7.
PubMed 31917991Legrand E. Aceclofenac in the management of inflammatory pain. Expert Opin Pharmacother. 2004 Jun;5(6):1347-57. doi: 10.1517/14656566.5.6.1347.
PubMed 15163279
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of a Clinical Scoring System to Predict Microscopic Colitis in Patients With Chronic Watery Diarrhoea
- ClinicalTrials.gov ID
- NCT06031064
- Acronym / sponsor ID
- P/22-108
- Conditions
- Microscopic Colitis
- Keywords
- Inflammatory bowel disease (IBD), clinical scoring, chronic watery diarrhea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Two diagnostic scoring systems have been proposed to predict the risk of developing MC: 1) The Kane score (sensitivity (SN) 96%; specificity (SP) 46%) combines eight risk factors, including female sex, age over 50 years, weight loss, absence of abdominal pain, and use of proton pump inhibitors (PPIs) and non-steroidal anti-inflammatory drugs (NSAIDs), presence of nocturnal diarrhoea and diarrhoea duration of less than 6 months. 2) The Cotter score (SN 93%; SP 49%) includes age ≥55 years, duration of diarrhoea ≤6 months, ≥5 bowel movements per day, body mass index <30 kg/m2, current smoking, and current use of selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors and NSAIDs. However, both scoring systems have been derived from retrospective studies and watery chronic diarrhoea, the hallmark clinical symptom of MC, was not well defined.
Besides MC risk factors, faecal markers could also be useful for MC screening. Most studies have found that 60-75% of the patients with active collagenous colitis, a subtype of MC, have elevated faecal calprotectin levels. Moreover, a recent study showed that faecal calprotectin concentrations >100 μg/g (AUC, 0.73) showed a 67% sensitivity and 75% specificity to predict MC.
To further assess the value of the Kane and Cotter scoring systems and to derive a new score including faecal calprotectin aiming to increase specificity, the investigators performed a prospective observational two-centres study. Chronic watery diarrhoea was defined as ≥2 watery stools (Bristol 6-7) per day, of frequent occurrence (≥3 times per week), of at least 1 month duration. A registry of demographic and clinical characteristics (VAS of 0-100 of abdominal pain and abdominal distension, presence of nocturnal diarrhoea, urgency and faecal incontinence, smoking, body mass index, weight loss, use of drugs) was performed. The study included 118 patients with chronic watery diarrhoea, from which 41 were diagnosed with MC (21 lymphocytic colitis, 16 collagenous colitis and 4 paucicellular colitis) and obtained lower SN and SP values than those published of the Cotter (SN 78%; SP 57%) and Kane (SN 78%; SP 38%) scores. The AUC of both scores was 0.71 and 0.66, respectively. The multivariate analysis identified 5 variables associated with MC: >5 stools/day (OR 12.5), duration of diarrhoea ≤8 months (OR 5), regular use of low-dose acetylsalicylic acid (ASA) (OR 4), BMI ≤26 Kg/m2 (OR 4.1) and faecal calprotectin >500 µg/g (OR 5.5). A new score was developed using the variables mentioned above with an AUC of 0.86 (p<0.001 vs. Kane and Cotter scores). A score >10 had a sensitivity of 61.5% and a specificity of 92%. A score >17 gave a specificity of 100% with a sensitivity of 36%. The score was internally validated using bootstrapping techniques.
Although promising, the new scoring system must be externally validated before generalizing its use in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic watery diarrhoea and clinical suspicion of MC | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients diagnosed with Microscopic Colitis (MC)
Time frame: up to 2 months (after clinical and histological assessment)
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
1 secondary outcome
Faecal calprotectin concentration (μg/g)
Time frame: at inclusion (prior to colonoscopy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 33619914Miehlke 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.
- Background: PubMed 16097993Beaugerie L, Pardi DS. Review article: drug-induced microscopic colitis - proposal for a scoring system and review of the literature. Aliment Pharmacol Ther. 2005 Aug 15;22(4):277-84. doi: 10.1111/j.1365-2036.2005.02561.x.
- Background: PubMed 24731750Larsson JK, Sjoberg K, Vigren L, Benoni C, Toth E, Olesen M. Chronic non-bloody diarrhoea: a prospective study in Malmo, Sweden, with focus on microscopic colitis. BMC Res Notes. 2014 Apr 14;7:236. doi: 10.1186/1756-0500-7-236.
- Background: PubMed 23344243Fernandez-Banares F, de Sousa MR, Salas A, Beltran B, Piqueras M, Iglesias E, Gisbert JP, Lobo B, Puig-Divi V, Garcia-Planella E, Ordas I, Andreu M, Calvo M, Montoro M, Esteve M, Viver JM; RECOMINA Project, GETECCU Grupo Espanol de Enfermedades de Crohn y Colitis Ulcerosa. Epidemiological risk factors in microscopic colitis: a prospective case-control study. Inflamm Bowel Dis. 2013 Feb;19(2):411-7. doi: 10.1002/ibd.23009.
- Background: PubMed 25616029Kane JS, Rotimi O, Everett SM, Samji S, Michelotti F, Ford AC. Development and validation of a scoring system to identify patients with microscopic colitis. Clin Gastroenterol Hepatol. 2015 Jun;13(6):1125-31. doi: 10.1016/j.cgh.2014.12.035. Epub 2015 Jan 20.
- Background: PubMed 27243102Kane JS, Sood R, Law GR, Gracie DJ, To N, Gold MJ, Ford AC. Validation and modification of a diagnostic scoring system to predict microscopic colitis. Scand J Gastroenterol. 2016 Oct;51(10):1206-12. doi: 10.1080/00365521.2016.1186221. Epub 2016 May 31.
- Background: PubMed 27404403Cotter TG, Binder M, Harper EP, Smyrk TC, Pardi DS. Optimization of a Scoring System to Predict Microscopic Colitis in a Cohort of Patients With Chronic Diarrhea. J Clin Gastroenterol. 2017 Mar;51(3):228-234. doi: 10.1097/MCG.0000000000000565.
- Background: PubMed 26597122Fernandez-Banares F, Casanova MJ, Arguedas Y, Beltran B, Busquets D, Fernandez JM, Fernandez-Salazar L, Garcia-Planella E, Guagnozzi D, Lucendo AJ, Mancenido N, Marin-Jimenez I, Montoro M, Piqueras M, Robles V, Ruiz-Cerulla A, Gisbert JP; Spanish Microscopic Colitis Group (SMCG). Current concepts on microscopic colitis: evidence-based statements and recommendations of the Spanish Microscopic Colitis Group. Aliment Pharmacol Ther. 2016 Feb;43(3):400-26. doi: 10.1111/apt.13477. Epub 2015 Nov 24.
- Background: PubMed 11051356Limburg PJ, Ahlquist DA, Sandborn WJ, Mahoney DW, Devens ME, Harrington JJ, Zinsmeister AR. Fecal calprotectin levels predict colorectal inflammation among patients with chronic diarrhea referred for colonoscopy. Am J Gastroenterol. 2000 Oct;95(10):2831-7. doi: 10.1111/j.1572-0241.2000.03194.x.
- Background: PubMed 17556903Wildt S, Nordgaard-Lassen I, Bendtsen F, Rumessen JJ. Metabolic and inflammatory faecal markers in collagenous colitis. Eur J Gastroenterol Hepatol. 2007 Jul;19(7):567-74. doi: 10.1097/MEG.0b013e328058ed76.
- Background: PubMed 21557718Wagner M, Peterson CG, Stolt I, Sangfelt P, Agnarsdottir M, Lampinen M, Carlson M. Fecal eosinophil cationic protein as a marker of active disease and treatment outcome in collagenous colitis: a pilot study. Scand J Gastroenterol. 2011 Jul;46(7-8):849-54. doi: 10.3109/00365521.2011.571707. Epub 2011 May 11.
- Background: PubMed 23118812Stoicescu A, Becheanu G, Dumbrava M, Gheorghe C, Diculescu M. Microscopic colitis - a missed diagnosis in diarrhea-predominant irritable bowel syndrome. Maedica (Bucur). 2012 Jan;7(1):3-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yamile Zabana, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microscopic Colitis, run by Hospital Mutua de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yamile Zabana, MD, PhD (yzabana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients diagnosed with Microscopic Colitis (MC) (time frame: up to 2 months (after clinical and histological assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06031064, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.