Treatment of Rumination
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biofeedback, Placebo.
- Who it may be relevant to
- Registry conditions: Rumination Syndrome. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Tratamiento de la rumiación: Estudio Aleatorizado, Paralelo y Controlado
Overview
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
- Behavioral Biofeedback
Three sessions of biofeedback before and after a standardized meal. - Dietary supplement Placebo
Three sessions of placebo followed by standardized meal.
Primary outcome measures
- Number of rumination events after a challenge meal measured by an event marker. [Time frame: 4 weeks]
Secondary outcome measures (5)
- Number of self perceived rumination events [Time frame: 4 weeks]
- Number of rumination events [Time frame: 1 month]
- Number of rumination events [Time frame: 3 months]
- Number of rumination events [Time frame: 6 months]
- Quantity of meal regurgitated [Time frame: 4 weeks]
Eligibility criteria
Inclusion criteria
- Rumination syndrome
Exclusion criteria
- Relevant organic diseases
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Vall d'Hebron Research Institute — Barcelona
Identifiers
NCT: NCT06971354 · PR(AG)057-2025