Simplified biofeedback treatment for rumination syndrome
Official title: Tratamiento de la rumiación: Estudio Aleatorizado, Paralelo y Controlado
Run by Hospital Universitari Vall d'Hebron Research Institute · NCT06971354 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 1 site (Barcelona) |
| Status | Recruiting |
| Started | May 2, 2025 |
| Main results expected | May 2026 |
| Study ends | October 2026 |
| Registry record updated | July 9, 2025 |
| Trial ID | NCT06971354 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies using instrumented biofeedback have demonstrated benefit for rumination syndrome, but simplified non-instrumental cognitive biofeedback approaches have been less widely tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Rumination syndrome Exclusion Criteria: * Relevant organic diseases
Where it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.