NCT06971354

Treatment of Rumination

Tratamiento de la rumiación: Estudio Aleatorizado, Paralelo y Controlado

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rumination Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Biofeedback	Three sessions of biofeedback before and after a standardized meal.
DIETARY_SUPPLEMENT	Placebo	Three sessions of placebo followed by standardized meal.

Timeline

• Start date: 2025-05-02
• Primary completion: 2026-05-01
• Completion: 2026-10-01
• First posted: 2025-05-14
• Last updated: 2025-07-09

Locations

1 site across 1 country: Spain