Dyspepsia
Conditions
Keywords
Functional dyspepsia, Abdominal distension
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.
Interventions
BEHAVIORALAbdominothoracic biofeedback
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 active comparator group.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Adaptive design: a sample size calculation based on the primary outcome will be performed after 30 patients complete the post-intervention evaluation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Rome IV Criteria for functional dyspepsia
Exclusion criteria
* organic gastrointestinal diseases * obesity * history of anosmia and ageusia * alcohol abuse * eating disorders Age- and-sex-matched healthy subjects will be included in parallel to the 30 first patients, to determine the normal values of the response to the probe meal. Healthy subjects will not undergo the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial fullness | 7 days | Change in postprandial fullness (measured on daily postprandial fullness scales graded from 0, i.e., not at all, to 10, i.e., extremely severe) during 7 consecutive days before and immediately after intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance of a probe meal | 60 minutes | Change in the amount of a probe meal tolerated (Kcal consumed) before and after intervention. |
| Digestive well-being after a probe meal | 60 minutes | Change in digestive well-being after a probe meal (measured on a scale graded from -5, i.e., extremely negative, to +5, i.e., extremely positive) before and after intervention |
| Postprandial fullness after a probe meal | 60 minutes | Change in postprandial fullness after a probe meal (measured on a scale graded from 0, i.e., not at all, to 10, i.e., extremely severe) before and after intervention |
| Abdominal distension in response to a probe meal | 60 minutes | Changes in the girth response to a probe meal (measured by adaptive belts) before and after intervention. |
| Diaphragmatic response to a probe meal | 60 minutes | Changes in the diaphragmatic response to a probe meal (measured by ultrasound) before and after intervention. |
Countries
Spain
Outcome results
None listed