The MODULATE study aimed to explore treatments for ongoing diarrhea in patients with stable ulcerative colitis (UC). Initially designed in 2019 for conventional in-person delivery, the trial had to adapt due to the COVID-19 pandemic, transitioning to a hybrid and later a fully decentralized model. Despite efforts to overcome recruitment challenges, including remote protocols for participant consent, intervention delivery, and data collection, the trial faced significant delays. Ultimately, only one participant was randomized, and the study had to close prematurely. The trial aimed to test a low FODMAP diet, low-dose amitriptyline, ondansetron, and loperamide against standard dietary advice in managing UC-related diarrhea.
Several redesign phases were implemented to address barriers, including the need for remote assessments and intervention delivery. However, the lack of site capacity, regulatory delays, and low recruitment rates led to the trial’s early termination. Despite the setback, the team gained significant experience in remote trial management, which could inform future studies. The MODULATE trial also highlighted the challenges of engaging the UC patient population and the importance of flexible recruitment strategies. Although no practice-changing results were obtained, the lessons learned from the trial’s design and delivery can guide future research on managing UC-associated diarrhea, particularly in underserved populations and in the context of primary care.
Reference: Moreau LA, Ford AC, Brookes MJ, et al. Management of diarrhoea in patients with stable ulcerative colitis with low FODMAP diet, amitriptyline, ondansetron or loperamide: the MODULATE RCT. Health Technol Assess. 2025 Mar 12:1-30. doi: 10.3310/GHFE4871. Epub ahead of print. PMID: 40079650; PMCID: PMC11931405.
