search
Back to results

Abdominothoracic Muscular Tone in Functional Dyspepsia

Primary Purpose

Dyspepsia

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Abdominothoracic biofeedback
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dyspepsia focused on measuring Functional dyspepsia, Abdominal distension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Vall d'HebronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Correction of abnormal somatic response to a meal

Sham intervention in patients with normal somatic response to a meal

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Tolerance of a probe meal
Change in the amount of a probe meal tolerated (Kcal consumed) before and after intervention.
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
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
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.
Diaphragmatic response to a probe meal
Changes in the diaphragmatic response to a probe meal (measured by ultrasound) before and after intervention.

Full Information

First Posted
June 8, 2022
Last Updated
July 5, 2023
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT05417204
Brief Title
Abdominothoracic Muscular Tone in Functional Dyspepsia
Official Title
Role of Abdominothoracic Muscular Activity on Symptoms of Functional Dyspepsia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
Functional dyspepsia, Abdominal distension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Adaptive design: a sample size calculation based on the primary outcome will be performed after 30 patients complete the post-intervention evaluation.
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Correction of abnormal somatic response to a meal
Arm Type
Experimental
Arm Description
Biofeedback in patients with functional dyspepsia and abnormal somatic response to a probe meal
Arm Title
Sham intervention in patients with normal somatic response to a meal
Arm Type
Active Comparator
Arm Description
Biofeedback in patients with functional dyspepsia and normal somatic response to a probe meal
Intervention Type
Behavioral
Intervention Name(s)
Abdominothoracic biofeedback
Intervention Description
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 Outcome Measure Information:
Title
Postprandial fullness
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Tolerance of a probe meal
Description
Change in the amount of a probe meal tolerated (Kcal consumed) before and after intervention.
Time Frame
60 minutes
Title
Digestive well-being after a probe meal
Description
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
Time Frame
60 minutes
Title
Postprandial fullness after a probe meal
Description
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
Time Frame
60 minutes
Title
Abdominal distension in response to a probe meal
Description
Changes in the girth response to a probe meal (measured by adaptive belts) before and after intervention.
Time Frame
60 minutes
Title
Diaphragmatic response to a probe meal
Description
Changes in the diaphragmatic response to a probe meal (measured by ultrasound) before and after intervention.
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando Azpiroz, MD
Phone
34 932746259
Email
azpiroz.fernando@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gloria Santaliestra
Phone
34 932746259
Email
gsantaliestra@vhebron.net
Facility Information:
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gloria Santaliestra
Phone
34 932746259

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33670508
Citation
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.
Results Reference
result

Learn more about this trial

Abdominothoracic Muscular Tone in Functional Dyspepsia

We'll reach out to this number within 24 hrs