Abdominothoracic Muscular Tone in Functional Dyspepsia

Dyspepsia Clinical Trial

Official title:

Role of Abdominothoracic Muscular Activity on Symptoms of Functional Dyspepsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417204
• Other study ID #: PR(AG)163/2022
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2023
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Fernando Azpiroz, MD
• Phone: 34 932746259
• Email: azpiroz.fernando[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tolerance of a probe meal	Change in the amount of a probe meal tolerated (Kcal consumed) before and after intervention.	60 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	Diaphragmatic response to a probe meal	Changes in the diaphragmatic response to a probe meal (measured by ultrasound) before and after intervention.	60 minutes