Abdominothoracic Muscular Tone in Functional Dyspepsia

NCT05417204 | Completed

• 1 other identifier: PR(AG)163/2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspepsia

Keywords

Functional dyspepsia; Abdominal distension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Tolerance of a probe meal

  60 minutes

• Digestive well-being after a probe meal

  60 minutes

• Postprandial fullness after a probe meal

  60 minutes

• Abdominal distension in response to a probe meal

  60 minutes

• Diaphragmatic response to a probe meal

  60 minutes

Study Arms (2)

Correction of abnormal somatic response to a meal

EXPERIMENTAL

Biofeedback in patients with functional dyspepsia and abnormal somatic response to a probe meal

Behavioral: Abdominothoracic biofeedback

Sham intervention in patients with normal somatic response to a meal

ACTIVE COMPARATOR

Biofeedback in patients with functional dyspepsia and normal somatic response to a probe meal

Behavioral: Abdominothoracic biofeedback

Interventions

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.

Correction of abnormal somatic response to a meal; Sham intervention in patients with normal somatic response to a meal

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rome IV Criteria for functional dyspepsia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Related 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.

  PMID: 33670508 RESULT

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 14, 2022
• Study Start: July 18, 2022
• Primary Completion: July 31, 2024
• Study Completion: September 30, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)