Treatment of Rumination

Not Applicable

Recruiting

• Conditions: Rumination Syndrome

• Registration Number: NCT06971354
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-02
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-06
• Study First Posted: 2025-05-14
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-09
• Primary Completion: 2026-05
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Rumination syndrome

Exclusion Criteria

• Relevant organic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	6 months	Number of rumination events measured by questionnaires administered daily for 7 days, 6 months 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.

Trial Locations

Locations (1)

Vall d'Hebron Research Institute; 🇪🇸 Barcelona, Spain