Abdominothoracic Muscular Tone in Functional Dyspepsia

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05417204

Collaborator

(none)

Enrollment

Location

Arms

14.4

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyspepsia	Behavioral: Abdominothoracic biofeedback	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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.Adaptive design: a sample size calculation based on the primary outcome will be performed after 30 patients complete the post-intervention evaluation.

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Other

Official Title:

Role of Abdominothoracic Muscular Activity on Symptoms of Functional Dyspepsia

Anticipated Study Start Date :

Jul 18, 2022

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Vall d'Hebron	Barcelona		Spain	08035

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital Universitari Vall d'Hebron Research Institute

ClinicalTrials.gov Identifier:

NCT05417204

Other Study ID Numbers:

PR(AG)163/2022

First Posted:

Jun 14, 2022

Last Update Posted:

Jul 6, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute

Functional dyspepsia

Abdominal distension

Additional relevant MeSH terms:

Dyspepsia

Study Results

No Results Posted as of Jul 6, 2022