Visible Abdominal Distension

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Irritable Bowel Syndrome, Dyspepsia, Functional Bloating

In brief

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.

Key facts

Study ID

NCT06369753

Run by

Hospital Universitari Vall d'Hebron Research Institute

People needed

100

Starts

2025-07-30

Expected to finish

2026-10-01

Last updated by the study team

2025-10-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• episodes of visible abdominal distension triggered by meal ingestion

You may not qualify if…

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

Where it is running

• G. Oppenheimer Center for Neurobiology of Stress and Resilience — Los Angeles, California, United States (enrolling)
• McMaster University — Hamilton, Ontario, Canada (enrolling)
• 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

Full record on ClinicalTrials.gov

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