ReviewAlimentary pharmacology & therapeutics2025
Review Article: Rome Foundation Working Team Report: Consensus Statement on the Design and Conduct of Behavioural Clinical Trials for Disorders of Gut-Brain Interaction.
Review in Alimentary pharmacology & therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed.
- Feasibility, Acceptability, and Preliminary Effects of a Nurse-Delivered Self-Management Program for Individuals with Inflammatory Bowel Disease: A Pilot Randomized Controlled Trial.Digestive diseases and sciences · 2026Trial
- A Randomized Waitlist-Controlled Trial of a Positive Psychology Intervention for Irritable Bowel Syndrome: The WISH Proof-of-Concept Trial.Neurogastroenterology and motility · 2025Trial
- To Clarify the Independent Role of Digital Learning and Nurse Support in the Self-Management of Inflammatory Bowel Disease.Digestive diseases and sciences · 2026Article
- The WISH 2.0 Intervention for Irritable Bowel Syndrome: Protocol for a Pilot Randomized Controlled Trial.JMIR research protocols · 2026Article
- The Challenges of Performing Controlled Trials of Diet Therapies in Gastroenterology.JGH open : an open access journal of gastroenterology and hepatology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
backgroundBrain-gut behaviour therapies (BGBT) have gained widespread acceptance as therapeutic modalities for the management of disorders of gut-brain interaction (DGBI). However, existing treatment evaluation methods in the medical field fail to capture the specific elements of scientific rigour unique to behavioural trial evaluation.
aimsTo offer the first consensus on the development and testing of BGBT in DGBI.
methodsAn international, interdisciplinary team of experts developed a consensus statement heavily informed by best practice recommendations for behavioural clinical trials for chronic diseases, organised by a selected treatment development model.
resultsWe suggest an existing behavioural treatment development model that has an iterative progression aligned with the drug development model with nuances specific to BGBT. We describe the iterative phases through initial discovery and experimental work, assembly of a mechanistic pathway and candidate treatment components, treatment refinement and optimisation, initial proof-of-concept, feasibility of clinical trials and, finally, confirmatory efficacy and effectiveness testing. We delineate recommendations for and provide examples that lend themselves to gastroenterologists planning to develop or test BGBT, reviewing proposals for or results from BGBT studies or writing management guidelines for DGBI.
conclusionsThis working team report facilitates a shared understanding of the elements of scientific rigour necessary for BGBT development and could support future standards on which BGBT are evaluated in gastroenterology.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.