Skip to main content
OpenTrials
Completed

NCT Number: NCT05417204

Abdominothoracic Muscular Tone in Functional Dyspepsia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abdominothoracic biofeedback

Behavioral

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.

Primary outcomes

  1. Postprandial fullness

    Time frame: 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 outcomes

  1. Tolerance of a probe meal

    Time frame: 60 minutes

    Change in the amount of a probe meal tolerated (Kcal consumed) before and after intervention.

  2. Digestive well-being after a probe meal

    Time frame: 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

  3. Postprandial fullness after a probe meal

    Time frame: 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

  4. Abdominal distension in response to a probe meal

    Time frame: 60 minutes

    Changes in the girth response to a probe meal (measured by adaptive belts) before and after intervention.

  5. Diaphragmatic response to a probe meal

    Time frame: 60 minutes

    Changes in the diaphragmatic response to a probe meal (measured by ultrasound) before and after intervention.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Role of Abdominothoracic Muscular Activity on Symptoms of Functional Dyspepsia

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2022
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.