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Study for Visible Abdominal Distension

This study is looking at a new way to help people with visible abdominal distension (a noticeable swelling of the belly). It's for individuals aged 18 to 80 who experience this symptom after eating, and who have conditions like Irritable Bowel Syndrome, Dyspepsia (indigestion), or Functional Bloating. The study will compare a behavioral therapy called Biofeedback, where you learn to control your abdominal muscles, with a Placebo (a sham treatment). The main goal is to see if Biofeedback can reduce visible abdominal distension after 4 weeks. The study aims to enroll 100 participants.

Study design
This is an interventional study that will randomly assign participants to either the Biofeedback or Placebo group. It plans to enroll 100 participants.
What's involved
You would attend three sessions of either Biofeedback or Placebo intervention during the first 3 weeks. The Biofeedback involves learning to control abdominal and thoracic (chest) muscles using video support, while the Placebo involves sham measurements.
Compensation
Not stated in the trial record.
Follow-up
Your visible abdominal distension will be measured at 4 weeks after the start of the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06369753

Visible Abdominal Distension

Recruiting
NAAges 18–80InterventionalTreatment
Hospital Universitari Vall d'Hebron Research Institute
~100 participants
Updated 2025-10-31 on ClinicalTrials.gov
What's tested:BiofeedbackPlacebo

At a glance

Recruiting sites
2 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Visible abdominal distension
Measured over 4 weeks

Conditions

Irritable Bowel Syndrome
Dyspepsia
Functional Bloating

Explore related trials

DyspepsiaFunctional bloatingIrritable Bowel Syndrome

Where it's being run

7 sites across 7 states
California1
Ontario1
France1
Italy1
Spain1
Sweden1
United Kingdom1

Study leadership

  • Fernando Azpiroz, MD · PRINCIPAL_INVESTIGATOR · University Hospital Vall d'Hebron

Who to contact

Fernando Azpiroz, MD
[email protected]
34 932746259
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

episodes of visible abdominal distension triggered by meal ingestion

Exclusion

organic cause detected by clinical work-up
constipation
abdominal distension not confirmed by the 7-day clinical questionnaires in the pre- intervention evaluation

What this trial measures

  • Visible abdominal distension4 weeks

    Distension score measured by scales graded from 0 (not at all) to 10 (very much) at the end of each day over a 7-day clinical evaluation period before and during the 4th week of the intervention.