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Beclomethasone dipropionate in microscopic colitis : results of an exploratory open-label multicentre study (COLCO)

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Abstract
Background: Budesonide has beenproven to be an effective treatment for microscopic colitis (MC). However, the two current commercially available preparations are released in the ileum. Beclomethasone dipropionate (Clipper (R)) is a synthetic corticosteroid with topical colonic release. Objective: This study aimed to explore whether an open-label treatment with beclomethasone dipropionate is an effective treatment for MC. Methods: Prospectively collected data of 30 patients from six centres were retrospectively analysed. All patients had a confirmed diagnosis of idiopathic MC (lymphocytic and collagenous colitis) and were symptomatic (i.e. >= 21 loose stools over a seven-day period). Treatment consisted of 10 mg beclomethasone daily for four weeks, followed by 5 mg daily for another four weeks. The primary end point was the proportion of patients in remission (i.e. a mean of < 3 stools/day and a mean of <1 watery stool per day) after an eight-week treatment period. Secondary end points were the proportion of patients responding to therapy at weeks 4 and 8, remission at weeks 4 and 12 and relapse at week 12. Reported adverse events were collected. Results: Overall, at week 8, remission was achieved in 70%, and 77% of patients were responding to treatment. After four weeks of treatment, 80% were responding, and 67% were in remission. Four weeks after stopping treatment, 60% were still in remission. Conclusion This open-label study suggests that an eight-week course of beclomethasone could be a promising and relatively safe treatment for MC. A randomised controlled study is warranted.
Keywords
ACTIVE ULCERATIVE-COLITIS, ORAL BECLOMETASONE DIPROPIONATE, DOUBLE-BLIND, COLLAGENOUS COLITIS, BUDESONIDE TREATMENT, LYMPHOCYTIC, COLITIS, DIAGNOSIS, IBD, microscopic colitis, lymphocytic colitis, collagenous colitis, beclomethasone dipropionate, budesonide

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MLA
De Corte, Thomas, et al. “Beclomethasone Dipropionate in Microscopic Colitis : Results of an Exploratory Open-Label Multicentre Study (COLCO).” UNITED EUROPEAN GASTROENTEROLOGY JOURNAL, vol. 7, no. 9, 2019, pp. 1183–88.
APA
De Corte, T., Janssens, E., D’Hondt, A., Thorrez, K., Arts, J., Dejaegher, K., … Baert, F. (2019). Beclomethasone dipropionate in microscopic colitis : results of an exploratory open-label multicentre study (COLCO). UNITED EUROPEAN GASTROENTEROLOGY JOURNAL, 7(9), 1183–1188.
Chicago author-date
De Corte, Thomas, Emilie Janssens, Ann D’Hondt, Koen Thorrez, Joris Arts, Katrien Dejaegher, Francois D’Heygere, et al. 2019. “Beclomethasone Dipropionate in Microscopic Colitis : Results of an Exploratory Open-Label Multicentre Study (COLCO).” UNITED EUROPEAN GASTROENTEROLOGY JOURNAL 7 (9): 1183–88.
Chicago author-date (all authors)
De Corte, Thomas, Emilie Janssens, Ann D’Hondt, Koen Thorrez, Joris Arts, Katrien Dejaegher, Francois D’Heygere, Annelies Holvoet, Bart van Besien, Luc Harlet, Harald Peeters, Wouter Van Moerkercke, and Filip Baert. 2019. “Beclomethasone Dipropionate in Microscopic Colitis : Results of an Exploratory Open-Label Multicentre Study (COLCO).” UNITED EUROPEAN GASTROENTEROLOGY JOURNAL 7 (9): 1183–1188.
Vancouver
1.
De Corte T, Janssens E, D’Hondt A, Thorrez K, Arts J, Dejaegher K, et al. Beclomethasone dipropionate in microscopic colitis : results of an exploratory open-label multicentre study (COLCO). UNITED EUROPEAN GASTROENTEROLOGY JOURNAL. 2019;7(9):1183–8.
IEEE
[1]
T. De Corte et al., “Beclomethasone dipropionate in microscopic colitis : results of an exploratory open-label multicentre study (COLCO),” UNITED EUROPEAN GASTROENTEROLOGY JOURNAL, vol. 7, no. 9, pp. 1183–1188, 2019.
@article{8647728,
  abstract     = {Background: Budesonide has beenproven to be an effective treatment for microscopic colitis (MC). However, the two current commercially available preparations are released in the ileum. Beclomethasone dipropionate (Clipper (R)) is a synthetic corticosteroid with topical colonic release.
Objective: This study aimed to explore whether an open-label treatment with beclomethasone dipropionate is an effective treatment for MC.
Methods: Prospectively collected data of 30 patients from six centres were retrospectively analysed. All patients had a confirmed diagnosis of idiopathic MC (lymphocytic and collagenous colitis) and were symptomatic (i.e. >= 21 loose stools over a seven-day period). Treatment consisted of 10 mg beclomethasone daily for four weeks, followed by 5 mg daily for another four weeks. The primary end point was the proportion of patients in remission (i.e. a mean of < 3 stools/day and a mean of <1 watery stool per day) after an eight-week treatment period. Secondary end points were the proportion of patients responding to therapy at weeks 4 and 8, remission at weeks 4 and 12 and relapse at week 12. Reported adverse events were collected.
Results: Overall, at week 8, remission was achieved in 70%, and 77% of patients were responding to treatment. After four weeks of treatment, 80% were responding, and 67% were in remission. Four weeks after stopping treatment, 60% were still in remission. Conclusion This open-label study suggests that an eight-week course of beclomethasone could be a promising and relatively safe treatment for MC. A randomised controlled study is warranted.},
  author       = {De Corte, Thomas and Janssens, Emilie and D'Hondt, Ann and Thorrez, Koen and Arts, Joris and Dejaegher, Katrien and D'Heygere, Francois and Holvoet, Annelies and van Besien, Bart and Harlet, Luc and Peeters, Harald and Van Moerkercke, Wouter and Baert, Filip},
  issn         = {2050-6406},
  journal      = {UNITED EUROPEAN GASTROENTEROLOGY JOURNAL},
  keywords     = {ACTIVE ULCERATIVE-COLITIS,ORAL BECLOMETASONE DIPROPIONATE,DOUBLE-BLIND,COLLAGENOUS COLITIS,BUDESONIDE TREATMENT,LYMPHOCYTIC,COLITIS,DIAGNOSIS,IBD,microscopic colitis,lymphocytic colitis,collagenous colitis,beclomethasone dipropionate,budesonide},
  language     = {eng},
  number       = {9},
  pages        = {1183--1188},
  title        = {Beclomethasone dipropionate in microscopic colitis : results of an exploratory open-label multicentre study (COLCO)},
  url          = {http://dx.doi.org/10.1177/2050640619860965},
  volume       = {7},
  year         = {2019},
}

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