Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT05417204
Brief Summary:
Background. Patients with functional dyspepsia report symptoms after eating without detectable cause. A recent proof-of-concept study demonstrated that in healthy subjects, the activity of the abdominal walls influences perception of digestive sensations, specifically, intentional abdominal distension (by a maneuver of diaphragmatic contraction) increased bloating sensation in response to a probe meal.
Aim. To determine the role of the abdominothoracic muscular activity on symptoms of functional dyspepsia.
Design. Parallel study in dyspeptic patients who have an abnormal somatic response to a probe meal (experimental group), and patients who do not (control group), comparing the effect of abdominophrenic biofeedback on dyspeptic symptoms. The probe meal will consist in stepwise ingestion of a comfort meal (hot ham and cheese sandwich plus orange juice) up to maximal satiation.
Intervention. A standard biofeedback technique (3 sessions over a 4-week period) directed at controlling the muscular activity (postural tone) of the abdominal walls, will serve as active intervention in the experimental group, and as a sham intervention in the control (active comparator) group.
The study outcomes will be measured before, immediately after and at 6 months after biofeedback: 1) Clinical symptoms measured by scales during 7 consecutive days. 2) Responses to the probe meal: (a) sensations measured by scales; (b) changes in girth by adaptive belts; (c) diaphragmatic position by abdominal ultrasound.
Relevance. The identification of a pathophysiological mechanism of dyspeptic symptoms could serve as an objective marker for diagnosis and as a target for the development of mechanistic treatments.
Study:
NCT05417204
Study Brief:
Protocol Section:
NCT05417204