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Visible Abdominal Distension
Tratamiento de la distensión Abdominal Funcional
Who can join
Ages 18 to 80 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
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.
What is being tested
- Biofeedback (behavioral)
- Placebo (behavioral)
Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Participants: 100 · Started: Jul 30, 2025
Contact the study team
- Fernando Azpiroz, MD · Phone: 34 932746259
- Jordi Serra, MD · Phone: 34 932746259
Official record on ClinicalTrials.gov — NCT06369753
Locations in the U.S.
| California | G. Oppenheimer Center for Neurobiology of Stress and Resilience, Los Angeles |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.