Efficacy of Beclomethasone Dipropionate in Lowering Fecal Calprotectin Levels in Patients with Ulcerative Colitis in Clinical Remission and at Risk of Relapse: The Becalcu Randomized, Controlled Trial Article Swipe
Daniel Ginard
,
Manuel Barreiro‐de Acosta
,
Pilar Nos
,
Irene Moraleja
,
Fernando Muñoz Núñez
,
Xavier Aldeguer
,
Ana Echarri
,
Albert Villòria
,
Sabino Riestra
,
Marta Maia Boscá-Watts
,
Yago González‐Lama
,
Vanesa Royo
,
Rocío Ferreiro‐Iglesias
,
Marisa Iborra
,
Ainara Elorza
,
Alejandra Fernández-Pordomingo
,
Miquel Sans
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1159/000540792
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1159/000540792
Introduction: Identifying novel treatment strategies for patients with ulcerative colitis (UC) and at risk of relapse is critical. The objective of this study was to assess the efficacy of beclomethasone dipropionate (BDP) in lowering fecal calprotectin (FC) levels in UC patients in clinical remission and at risk of relapse. Methods: This multicenter study comprised a double-blind, randomized, placebo-controlled phase (part I) and an open-label, non-randomized phase (part II). Eligible participants with UC in clinical remission treated with 5-aminosalicylic acid and with FC levels ≥250 μg/g were randomized to receive 5 mg/day of BDP or placebo for 4 weeks (part I). At week 5, patients with FC ≥100 μg/g were treated with 5 mg/day of BDP for 4 weeks (part II), and FC levels were tested at week 9. Results: Forty-three patients were randomized: 22 received BDP (group A) and 21 placebo (group B). At week 4, 13 patients (59.1%) in group A and 3 (17.6%) in group B had FC levels <100 μg/g (p value = 0.010). In the double-blind phase of the study, no patient relapsed in group A and 4 in group B (p value = 0.049). Both treatment groups showed a favorable safety profile, with the most common adverse events being gastrointestinal disorders. Conclusion: In this multicenter, randomized clinical trial including patients with UC in clinical remission but with elevated FC, BDP was efficacious in reducing FC and well-tolerated.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1159/000540792
- OA Status
- hybrid
- References
- 34
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4401738610
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W4401738610Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1159/000540792Digital Object Identifier
- Title
-
Efficacy of Beclomethasone Dipropionate in Lowering Fecal Calprotectin Levels in Patients with Ulcerative Colitis in Clinical Remission and at Risk of Relapse: The Becalcu Randomized, Controlled TrialWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2024Year of publication
- Publication date
-
2024-08-22Full publication date if available
- Authors
-
Daniel Ginard, Manuel Barreiro‐de Acosta, Pilar Nos, Irene Moraleja, Fernando Muñoz Núñez, Xavier Aldeguer, Ana Echarri, Albert Villòria, Sabino Riestra, Marta Maia Boscá-Watts, Yago González‐Lama, Vanesa Royo, Rocío Ferreiro‐Iglesias, Marisa Iborra, Ainara Elorza, Alejandra Fernández-Pordomingo, Miquel SansList of authors in order
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https://doi.org/10.1159/000540792Publisher landing page
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YesWhether a free full text is available
- OA status
-
hybridOpen access status per OpenAlex
- OA URL
-
https://doi.org/10.1159/000540792Direct OA link when available
- Concepts
-
Medicine, Ulcerative colitis, Calprotectin, Internal medicine, Randomized controlled trial, Placebo, Gastroenterology, Adverse effect, Clinical trial, Inflammatory bowel disease, Disease, Pathology, Alternative medicineTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
0Total citation count in OpenAlex
- References (count)
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34Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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