Clinical trial NCT06971354: Treatment of Rumination: a Randomized, Parallel, Controlled Study
Official title: Tratamiento de la rumiación: Estudio Aleatorizado, Paralelo y Controlado
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rumination Syndrome
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Rumination syndrome

Exclusion Criteria:

* Relevant organic diseases

Primary outcomes:
measure: Number of rumination events after a challenge meal measured by an event marker.
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of self perceived rumination events
timeFrame: 4 weeks
measure: Number of rumination events
timeFrame: 1 month
measure: Number of rumination events
timeFrame: 3 months
measure: Number of rumination events
timeFrame: 6 months
measure: Quantity of meal regurgitated
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron Research Institute
Study officials:
affiliation: Vall d'Hebron Research Institute, Barcelona, 08035
name: Jordi Serra, M.D.
role: PRINCIPAL_INVESTIGATOR
References: