Simplified biofeedback treatment for rumination syndrome
Tratamiento de la rumiación: Estudio Aleatorizado, Paralelo y Controlado
This study will test whether a simplified, non-instrumental biofeedback method with brief cognitive coaching can reduce involuntary regurgitation in people with rumination syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06971354 on ClinicalTrials.gov |
What this trial studies
Rumination syndrome involves involuntary regurgitation driven by maladaptive abdominal muscle contractions and relaxation of the esophageal sphincters. This randomized, parallel-group interventional study will compare a streamlined non-instrumental biofeedback technique incorporating cognitive intervention against a placebo control with balanced sex distribution. The approach aims to teach behavioral reversal of the contractions using a simpler protocol than prior instrumented methods. Outcomes will focus on changes in symptom frequency and patient-reported improvement over the treatment period.
Who should consider this trial
Good fit: People with a clinical diagnosis of rumination syndrome who do not have relevant organic gastrointestinal disease and can attend the Vall d'Hebron Research Institute in Barcelona are ideal candidates.
Not a fit: Patients with relevant organic gastrointestinal diseases, other major swallowing disorders, or those unable to engage with behavioral/cognitive techniques or attend site visits are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could provide an accessible, low-cost therapy that reduces regurgitation episodes and improves daily functioning.
How similar studies have performed: Previous studies using instrumented biofeedback have demonstrated benefit for rumination syndrome, but simplified non-instrumental cognitive biofeedback approaches have been less widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Rumination syndrome Exclusion Criteria: * Relevant organic diseases
Where this trial is running
Barcelona
- Vall d'Hebron Research Institute — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Jordi Serra, M.D. — Vall d'Hebron Research Institute, Barcelona, 08035
- Study coordinator: Jordi Serra, M.D.
- Email: jordiserra@vallhebron.cat
- Phone: 34 93 274 6259
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.