Treatment of Rumination: a Randomized, Parallel, Controlled Study

Not Applicable

Not yet recruiting

• Conditions: Rumination Syndrome

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

Brief Summary

Background: Rumination syndrome is defined as the involuntary return of ingested food from the stomach to the mouth due to an involuntary contraction of the abdominal muscles with concomitant opening of the esophageal sphincters. Based on this, a biofeedback technique focusing on muscular activity has been developed and shown to be effective. However, these techniques are complex and not widely applicable.

Hypothesis: Rumination can be effectively corrected using a simplified, non-instrumental biofeedback technique based on cognitive intervention.

Objective: To test the efficacy of a non-instrumental biofeedback technique using cognitive intervention to correct rumination. The methodology will follow previous studies but with a simplified biofeedback approach.

Methods: In parallel groups with balanced sex distribution, the response to biofeedback treatment versus a control treatment will be measured. Over four weeks, three treatment sessions will be conducted:

The biofeedback group will be trained to control abdominothoracic musculature using cognitive intervention (supported by original graphic material) before and after a standardized test meal.

The control group will be given a placebo capsule before the test meal, and episodes of regurgitation will be recorded.

After the first session, patients in the biofeedback group will perform daily exercises, while those in the control group will continue taking a placebo with each meal. Treatment response will be assessed by comparing pre- and post-treatment measurements. Patients from the control group will be offered biofeedback treatment after their immediate post-treatment evaluation.

Relevance: This project will help determine the effectiveness of a simplified mechanistic treatment for rumination. If proven effective, this approach could be implemented in other centers.

Detailed Description

Not available

Study Timeline

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

Recruitment & Eligibility

• Status: NOT_YET_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 register 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 6 months after treatment.
Quantity of meal regurgitated	4 weeks	The quantity of the standardized meal regurigitated will be recorded and the proportion of the regurgitated / ingested meal will be completed.

Trial Locations

Locations (1)

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