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Treatment of Rumination

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated July 9, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of May 2025 to May 2, 2025
    • Secondary endpoints: details revised at 4 of 5 entries
    • Site details revised
    • Study title shortened, about 5 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06971354
Lead Sponsor Hospital Universitari Vall d'Hebron Research Institute
Conditions
(from sponsor)
Rumination Syndrome
Related terms Rumination Syndrome
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov