Video-guided training to reduce visible abdominal bloating
Tratamiento de la distensión Abdominal Funcional
This project tries a simple video-guided biofeedback program versus a sham program to see if it reduces visible belly swelling after meals in people with IBS, dyspepsia, or functional bloating.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 7 sites (Los Angeles, California and 6 other locations) |
| Trial ID | NCT06369753 on ClinicalTrials.gov |
What this trial studies
Participants with meal-triggered visible abdominal distension are randomized to receive either a noninstrumental biofeedback program delivered via standardized video instruction or a placebo (sham) intervention. Each participant undergoes three sessions during the first three weeks, with one trained operator per center delivering the protocol. Key exclusions include organic causes, constipation, or lack of confirmed distension on a 7-day pre-intervention diary. The multicenter design aims to test whether this simpler, equipment-free approach can reproduce earlier positive results obtained with instrumented biofeedback.
Who should consider this trial
Good fit: Ideal candidates are people who experience visible abdominal distension clearly triggered by meals and confirmed on a 7-day symptom diary, without constipation or an identified organic cause.
Not a fit: Patients with an identified organic cause of distension, those with constipation, or those whose distension is not confirmed on pre-intervention evaluation are unlikely to benefit from this behavioral program.
Why it matters
Potential benefit: If successful, this program could provide a simple, equipment-free way to reduce visible post-meal abdominal distension and improve comfort and daily functioning.
How similar studies have performed: Previous randomized placebo-controlled work by the authors showed instrumented biofeedback was superior to placebo, but this simplified noninstrumental video-guided technique is novel and still needs confirmation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California and 6 other locations
- G. Oppenheimer Center for Neurobiology of Stress and Resilience — Los Angeles, California, United States (Recruiting)
- McMaster University — Hamilton, Ontario, Canada (Recruiting)
- Bordeaux University Hospital — Bordeaux, France (Active_not_recruiting)
- Santa Orsola Hospital — Bologna, Italy (Active_not_recruiting)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (Not_yet_recruiting)
- Sahlgrenska Hospital, Gothenburg — Gothenburg, Sweden (Active_not_recruiting)
- Manchester University — Manchester, United Kingdom (Active_not_recruiting)
Study contacts
- Principal investigator: Fernando Azpiroz, MD — University Hospital Vall d'Hebron
- Study coordinator: Fernando Azpiroz, MD
- Email: azpiroz.fernando@gmail.com
- Phone: 34 932746259
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.