Vall d'Hebron Research Institute
Barcelona, 08035, Spain
Location status: Recruiting
NCT Number: NCT06971354
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Barcelona, 08035, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Three sessions of biofeedback before and after a standardized meal.
Three sessions of placebo followed by standardized meal.
Time frame: 4 weeks
Each regurgitation event will be registered by the patient using an event marker.
Time frame: 4 weeks
Number of rumination events measured by questionnaires administered daily for 7 days before and at the end of treatment.
Time frame: 1 month
Number of rumination events measured by questionnaires administered daily for 7 days, 1 month after treatment.
Time frame: 3 months
Number of rumination events measured by questionnaires administered daily for 7 days, 3 months after treatment.
Time frame: 6 months
Number of rumination events measured by questionnaires administered daily for 7 days, 6 months after treatment.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Gloria Santaliestra
CONTACT
Jordi Serra, M.D.
CONTACT
Hospital Universitari Vall d'Hebron Research Institute
Other
Tratamiento de la rumiación: Estudio Aleatorizado, Paralelo y Controlado
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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