Registered therapeutic trials in adults with functional dyspepsia: a scoping review of design and registration characteristics.
- 1College of Traditional Chinese Medicine, Changchun University of Chinese Medicine, Changchun, China.
- 2Department of Liver, Spleen and Stomach Diseases, The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun University of Chinese Medicine, Changchun, China.
Abstract
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. 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. 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%). 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.
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BibTeX
@article{yao2026registered,
title = {{Registered therapeutic trials in adults with functional dyspepsia: a scoping review of design and registration characteristics.}},
author = {Kangmeng Yao and Yixuan Lang and Wei Deng and Shuo Zhang and Sheng Liu and Yan Leng},
journal = {Frontiers in medicine},
year = {2026},
month = oct,
doi = {10.3389/fmed.2026.1956161},
url = {https://europepmc.org/article/MED/42952637},
note = {CC BY},
}
RIS
TY - JOUR
TI - Registered therapeutic trials in adults with functional dyspepsia: a scoping review of design and registration characteristics.
AU - Kangmeng Yao
AU - Yixuan Lang
AU - Wei Deng
AU - Shuo Zhang
AU - Sheng Liu
AU - Yan Leng
PY - 2026
DA - 2026/10/14
JO - Frontiers in medicine
DO - 10.3389/fmed.2026.1956161
UR - https://europepmc.org/article/MED/42952637
AB - 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. 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. 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%). 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.
SN - 2296-858X
ER -