Registered therapeutic trials in adults with functional dyspepsia: a scoping review of design and registration characteristics
Year: 2026
Type: article
Study design: Systematic Review
Abstract: Background: Functional dyspepsia (FD) affects quality of life and healthcare use. Previous studies have examined individual aspects of FD trial methodology, but a broad account of registered therapeutic trials is still needed. This scoping review mapped their design and registration characteristics to inform future trial design and reporting. Methods: WHO International Clinical Trials Registry Platform (ICTRP) was searched on 4 September 2026 for registered therapeutic interventional trials in adults with FD. Records referring to the same trial were linked into one trial unit. Two reviewers independently screened trial groups and assessed trial-level eligibility. Corresponding source registries were checked when ICTRP information was missing, incomplete, or inconsistent. Analyses were descriptive. Results: The review included 421 underlying registered trials, of which 191 (45.4%) were first registered during 2021-2026. Randomized allocation was recorded in 315 trials (74.8%), and 324 (77.0%) used parallel-group designs. Registration preceded the recorded study start date in 252 trials (59.9%). An explicit Rome diagnostic version was identified in 278 trials (66.0%). Primary outcomes were specified in 417 trials (99.0%), with FD symptoms represented in 374 (88.8%). A named primary FD symptom instrument was identified in 166 trials (39.4%). A safety or adverse-event outcome was identified in 103 trials (24.5%), intervention duration in 149 (35.4%), and post-intervention follow-up duration in 15 (3.6%). Conclusion: Registered FD trials cover a range of pharmacological and non-pharmacological interventions, but the documentation of eligibility criteria, masking, symptom measures, safety-related outcomes, intervention duration, and post-intervention follow-up varies. Earlier registration and clearer reporting of these elements would help readers interpret trial designs and compare studies.
Source: Frontiers in Medicine
Language: English
Subfield: Gastroenterology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,801
OpenAlex ID: W7221786306