RecruitingNot ApplicableNCT06369753

Visible Abdominal Distension

Tratamiento de la distensión Abdominal Funcional


Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrollment

100 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria1

  • episodes of visible abdominal distension triggered by meal ingestion

Exclusion Criteria3

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

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Interventions

BEHAVIORALBiofeedback

Three sessions of biofeedback intervention will be performed during the first 3 weeks of the intervention period. Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period

BEHAVIORALPlacebo

Three sessions of placebo intervention will be performed during the first 3 weeks of the intervention period. 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.


Locations(7)

G. Oppenheimer Center for Neurobiology of Stress and Resilience

Los Angeles, California, United States

McMaster University

Hamilton, Ontario, Canada

Bordeaux University Hospital

Bordeaux, France

Santa Orsola Hospital

Bologna, Italy

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Sahlgrenska Hospital, Gothenburg

Gothenburg, Sweden

Manchester University

Manchester, United Kingdom

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NCT06369753


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