Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT06369753

Visible Abdominal Distension

Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2025-10-31

100

Participants Needed

7

Research Sites

61 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical. Aim. To prove the efficacy of a noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers. Selection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period. Biofeedback: Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period. Placebo: Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.

CONDITIONS

Official Title

Visible Abdominal Distension

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Episodes of visible abdominal distension triggered by meal ingestion
Not Eligible

You will not qualify if you...

  • Organic cause detected by clinical work-up
  • Constipation
  • Abdominal distension not confirmed by the 7-day clinical questionnaires in the pre-intervention evaluation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 7 locations

1

G. Oppenheimer Center for Neurobiology of Stress and Resilience

Los Angeles, California, United States, 90095

Actively Recruiting

2

McMaster University

Hamilton, Ontario, Canada, ON L8S 4L8

Actively Recruiting

3

Bordeaux University Hospital

Bordeaux, France, 33000

Active, Not Recruiting

4

Santa Orsola Hospital

Bologna, Italy, 40138

Active, Not Recruiting

5

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Not Yet Recruiting

6

Sahlgrenska Hospital, Gothenburg

Gothenburg, Sweden, 413 45

Active, Not Recruiting

7

Manchester University

Manchester, United Kingdom, M14 9PR

Active, Not Recruiting

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Research Team

F

Fernando Azpiroz, MD

CONTACT

J

Jordi Serra, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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