Abdominothoracic Muscular Tone in Functional Dyspepsia

Role of Abdominothoracic Muscular Activity on Symptoms of 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.

Study Overview

• Status: Recruiting
• Conditions: Dyspepsia
• Intervention / Treatment: Behavioral: Abdominothoracic biofeedback

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernando Azpiroz, MD; Phone Number: 34 932746259; Email: azpiroz.fernando@gmail.com
• Study Contact Backup: Name: Gloria Santaliestra; Phone Number: 34 932746259; Email: gsantaliestra@vhebron.net

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Vall d'Hebron
    • Contact: Gloria Santaliestra
    • Contact: Phone Number: 34 932746259

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Correction of abnormal somatic response to a meal; Biofeedback in patients with functional dyspepsia and abnormal somatic response to a probe meal	Behavioral: Abdominothoracic 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.
Active Comparator: Sham intervention in patients with normal somatic response to a meal; Biofeedback in patients with functional dyspepsia and normal somatic response to a probe meal	Behavioral: Abdominothoracic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial fullness	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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance of a probe meal	Change in the amount of a probe meal tolerated (Kcal consumed) before and after intervention.	60 minutes
Digestive well-being after a probe meal	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	60 minutes
Postprandial fullness after a probe meal	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	60 minutes
Abdominal distension in response to a probe meal	Changes in the girth response to a probe meal (measured by adaptive belts) before and after intervention.	60 minutes
Diaphragmatic response to a probe meal	Changes in the diaphragmatic response to a probe meal (measured by ultrasound) before and after intervention.	60 minutes

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

General Publications

• Livovsky DM, Barber C, Barba E, Accarino A, Azpiroz F. Abdominothoracic Postural Tone Influences the Sensations Induced by Meal Ingestion. Nutrients. 2021 Feb 18;13(2):658. doi: 10.3390/nu13020658.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Functional dyspepsia; Abdominal distension
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: PR(AG)163/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No