Rumination Syndrome
Conditions
Brief summary
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.
Interventions
BEHAVIORALBiofeedback
Three sessions of biofeedback before and after a standardized meal.
DIETARY_SUPPLEMENTPlacebo
Three sessions of placebo followed by standardized meal.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Rumination syndrome
Exclusion criteria
* Relevant organic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of rumination events after a challenge meal measured by an event marker. | 4 weeks | Each regurgitation event will be registered by the patient using an event marker. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of self perceived rumination events | 4 weeks | Number of rumination events measured by questionnaires administered daily for 7 days before and at the end of treatment. |
| Number of rumination events | 1 month | Number of rumination events measured by questionnaires administered daily for 7 days, 1 month after treatment. |
| Quantity of meal regurgitated | 4 weeks | The quantity of the standardized meal that is regurgitated will be recorded, and the proportion of regurgitated to ingested meal will be calculated. |
Countries
Spain
Contacts
Primary ContactJordi Serra, M.D.
Backup ContactGloria Santaliestra
Outcome results
None listed