Ovadia B, Niv E, Stern Katie S, Mahajna E, Gal O, Kopelman Y. Effect of Modulen vs budesonide on clinical response and mucosal healing in Crohn’s patients. World J Gastroenterol 2025; 31(5): 100238 [DOI: 10.3748/wjg.v31.i5.100238]
Corresponding Author of This Article
Eva Niv, MD, Academic Research, Department of Gastroenterology, Meuhedet Health Services, Kibutz Galuet 9 Hadera, Hadera 38100, Haifa, Israel. niveva022@gmail.com
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Clinical Trials Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Gastroenterol. Feb 7, 2025; 31(5): 100238 Published online Feb 7, 2025. doi: 10.3748/wjg.v31.i5.100238
Effect of Modulen vs budesonide on clinical response and mucosal healing in Crohn’s patients
Baruch Ovadia, Eva Niv, Sara Stern Katie, Elisabeth Mahajna, Oren Gal, Yael Kopelman
Baruch Ovadia, Sara Stern Katie, Elisabeth Mahajna, Oren Gal, Yael Kopelman, Department of Gastroenterology, Hillel Yaffe Medical Center, Hadera 38100, Haifa, Israel
Baruch Ovadia, Oren Gal, Yael Kopelman, Faculty of Medicine, Technion-Israel Institute of Technology, Hadera 38100, Haifa, Israel
Eva Niv, Department of Gastroenterology, Meuhedet Health Services, Hadera 38100, Haifa, Israel
Co-first authors: Baruch Ovadia and Eva Niv.
Author contributions: Ovadia B and Niv E designed the study, collected and analyzed the data, and drafted the manuscript; Gal O and Kopelman Y assisted in designing the study and manuscript drafting; Kopelman Y supervised the study; Stern Katie S and Mahajna E collected the data and contributed to data analysis; All authors read and approved the final manuscript.
Institutional review board statement: The study was reviewed and approved by the ethics committee of the Hillel Yaffe Medical Center, affiliated with Technion, Haifa, Israel (No. HYMC 0128-18).
Clinical trial registration statement: The study was registered on https://clinicaltrials.gov/ under the number NCT04233463.
Informed consent statement: All patients provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Eva Niv, MD, Academic Research, Department of Gastroenterology, Meuhedet Health Services, Kibutz Galuet 9 Hadera, Hadera 38100, Haifa, Israel. niveva022@gmail.com
Received: August 10, 2024 Revised: November 21, 2024 Accepted: December 16, 2024 Published online: February 7, 2025 Processing time: 141 Days and 19.1 Hours
Abstract
BACKGROUND
Mucosal healing has become an important goal of Crohn’s disease (CD) treatments. Modulen, enriched with transforming growth factor-beta 2, and budesonide are commonly accepted treatments for mild-moderate CD. However, their effects on the small bowel (SB) mucosa remain underexplored.
AIM
To prospectively assess clinical and mucosal responses to Modulen vs budesonide in adults with CD, using SB capsule endoscopy.
METHODS
Thirty patients were divided into two groups: Modulen + home-based diet (21 patients) and budesonide (9 patients) for an eight-week intervention followed by four weeks of follow-up. Clinical, laboratory, and endoscopic responses were evaluated. The mucosal changes were assessed through SB capsule endoscopy.
RESULTS
Results indicated significant clinical improvement in the Modulen group with reduced CD activity index (P = 0.041) and improved inflammatory bowel disease questionnaire score (P = 0.016). Moreover, Modulen was associated with a significant SB mucosal improvement, evidenced by a decrease in Lewis score (P = 0.027). No significant changes were observed in calprotectin or other laboratory parameters. Conversely, budesonide exhibited more modest clinical effects, but it improved calprotectin, hemoglobin, and C-reactive protein levels (P = 0.051, P = 0.014, and P = 0.038, respectively). The capsule endoscopy did not reveal a significant mucosal response in the budesonide group.
CONCLUSION
Both interventions have a role in CD treatment. Yet, their effects differ and may complement each other: Modulen yields clinical and mucosal improvements, while budesonide primarily leads mainly to laboratory improvements.
Core Tip: The effects of Modulen and budesonide on mucosal healing in Crohn’s disease remain underexplored. In this study, the small bowel capsule endoscopy was used for the first time to compare the mucosal effect of Modulen and budesonide on patients with newly diagnosed mild-moderate Crohn’s disease. The study results demonstrate that Modulen shows significant clinical and mucosal improvements, while budesonide primarily improves laboratory parameters. The complementary effect of both of them should be explored to maximize the benefit to the patients.
