An interventional study of Biofeedback and Placebo in Rumination Syndrome, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Treatment
Background: Rumination syndrome is characterized by the involuntary regurgitation of previously ingested food from the stomach to the mouth, triggered by an unintentional contraction of the abdominal muscles along with simultaneous relaxation of the esophageal sphincters. Based on this mechanism, a biofeedback technique targeting muscular activity has been developed and shown to be effective. However, such techniques are often complex and not widely accessible.
Hypothesis: Rumination can be effectively treated using a simplified, non-instrumental biofeedback technique based on cognitive intervention.
Objective: To evaluate the effectiveness of a non-instrumental biofeedback technique incorporating cognitive intervention for the treatment of rumination. The methodology will build on prior studies, employing a more streamlined biofeedback approach.
Methods: Participants will be assigned to parallel groups with balanced sex distribution. The study will compare responses to biofeedback versus a control intervention. Over a four-week period, each participant will undergo three treatment sessions:
The biofeedback group will be trained to control abdominothoracic musculature through cognitive intervention, supported by original visual materials, both before and after a standardized test meal.
The control group will receive a placebo capsule prior to the test meal, and regurgitation episodes will be recorded.
Following the initial session, biofeedback participants will continue with daily exercises, while control participants will take a placebo with each meal. Treatment response will be assessed by comparing outcomes before and after the intervention. After post-treatment assessment, control group participants will be offered the opportunity to receive biofeedback therapy.
Relevance: This project aims to determine the efficacy of a simplified mechanistic intervention for rumination. If successful, this approach could be adopted in additional healthcare settings.
72 studies on the registry are indexed under Rumination Syndrome; 22 are open to participants now.
This study's planned enrollment of 40 is below the median of 62 across 63 interventional studies indexed under Rumination Syndrome.
Browse Rumination Syndrome studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Three biofeedback sessions will be administered during the first three weeks of the intervention period. In each session, participants will receive a standardized meal and undergo training to control abdominal and thoracic muscular activity. This training will be guided by a trained operator using original audiovisual materials and hands-on techniques. Regurgitation episodes will be recorded by participants using an event marker. Following each session, participants will be instructed to perform the same exercises before and after breakfast, lunch, and dinner throughout the four-week intervention period.
Behavioral: Biofeedback
Three treatment sessions will be conducted during the first three weeks of the intervention period. In each session, participants will receive a placebo capsule prior to a standardized meal and will be instructed to record the number of regurgitation episodes using an event marker. Following each session, participants will be asked to take a placebo capsule before each meal throughout the four-week intervention period.
Dietary Supplement: Placebo
Three sessions of biofeedback before and after a standardized meal.
Three sessions of placebo followed by standardized meal.
Number of rumination events after a challenge meal measured by an event marker.
Each regurgitation event will be registered by the patient using an event marker.
Time frame: 4 weeks
Number of self perceived rumination events
Number of rumination events measured by questionnaires administered daily for 7 days before and at the end of treatment.
Time frame: 4 weeks
Number of rumination events
Number of rumination events measured by questionnaires administered daily for 7 days, 1 month after treatment.
Time frame: 1 month
Number of rumination events
Number of rumination events measured by questionnaires administered daily for 7 days, 3 months after treatment.
Time frame: 3 months
Number of rumination events
Number of rumination events measured by questionnaires administered daily for 7 days, 6 months after treatment.
Time frame: 6 months
Quantity of meal regurgitated
The quantity of the standardized meal that is regurgitated will be recorded, and the proportion of regurgitated to ingested meal will be calculated.
Time frame: 4 weeks
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Universitari Vall d'Hebron Research Institute