Back to Trials
NCT06369753NARecruitingAccepts Healthy Volunteers

Visible Abdominal Distension

Hospital Universitari Vall d'Hebron Research Institute

Start Date

7/30/2025

Completion Date

10/1/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to 80 years

Inclusion Criteria: * episodes of visible abdominal distension triggered by meal ingestion Exclusion Criteria: * organic cause detected by clinical work-up * constipation * abdominal distension not confirmed by the 7-day clinical questionnaires in the pre- intervention evaluation

Interventions

BEHAVIORAL

Biofeedback

BEHAVIORAL

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Irritable Bowel SyndromeDyspepsiaFunctional Bloating

Locations

G. Oppenheimer Center for Neurobiology of Stress and Resilience

Los Angeles, California 90095

United States

McMaster University

Hamilton, Ontario ON L8S 4L8

Canada

Bordeaux University Hospital

Bordeaux, 33000

France

Santa Orsola Hospital

Bologna, 40138

Italy

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Sahlgrenska Hospital, Gothenburg

Gothenburg, 413 45

Sweden

Manchester University

Manchester, M14 9PR

United Kingdom