Visible Abdominal Distension
Key facts
- Who runs it
- Hospital Universitari Vall d'Hebron Research Institute
- Where
- Bologna, ItalySee the siteAlso in 6 other countries, 6 sites
- Trial code
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 30 Jul 2025
- Planned end
- Oct 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Biofeedback
- Placebo
- Record updated
- 31 October 2025
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- episodes of visible abdominal distension triggered by meal ingestion
Who cannot take part
- organic cause detected by clinical work-up
- constipation
- abdominal distension not confirmed by the 7-day clinical questionnaires in the pre- intervention evaluation
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Italy
Also in 6 other countries, 6 sites
- Santa Orsola HospitalBologna, ItalyContact: Fernando Azpiroz, MDNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- BiofeedbackTreatment being tested
- PlaceboPlacebo, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Tratamiento de la distensión Abdominal Funcional
- Fit questions
- Built from NCT06369753, who can take part
- Record updated
- 31 October 2025