Treatment of Rumination

NCT06971354 | Recruiting

• 1 other identifier: PR(AG)057-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Rumination Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of rumination events after a challenge meal measured by an event marker.

  Each regurgitation event will be registered by the patient using an event marker.

  4 weeks

Secondary Outcomes (5)

• Number of self perceived rumination events

  4 weeks

• Number of rumination events

  1 month

• Number of rumination events

  3 months

• Number of rumination events

  6 months

• Quantity of meal regurgitated

  4 weeks

Study Arms (2)

Biofeedback

EXPERIMENTAL

Three biofeedback sessions will be administered during the first three weeks of the intervention period. In each session, participants will receive a standardized meal and undergo training to control abdominal and thoracic muscular activity. This training will be guided by a trained operator using original audiovisual materials and hands-on techniques. Regurgitation episodes will be recorded by participants using an event marker. Following each session, participants will be instructed to perform the same exercises before and after breakfast, lunch, and dinner throughout the four-week intervention period.

Behavioral: Biofeedback

Placebo

PLACEBO COMPARATOR

Three treatment sessions will be conducted during the first three weeks of the intervention period. In each session, participants will receive a placebo capsule prior to a standardized meal and will be instructed to record the number of regurgitation episodes using an event marker. Following each session, participants will be asked to take a placebo capsule before each meal throughout the four-week intervention period.

Dietary Supplement: Placebo

Interventions

Biofeedback BEHAVIORAL

Three sessions of biofeedback before and after a standardized meal.

Biofeedback

Placebo DIETARY_SUPPLEMENT

Three sessions of placebo followed by standardized meal.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rumination syndrome

You may not qualify if:

• Relevant organic diseases

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Vall d'Hebron Research Institute

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Rumination Syndrome

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Jordi Serra, M.D.

  Vall d'Hebron Research Institute, Barcelona, 08035

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi Serra, M.D.

CONTACT

34 93 274 6259; jordiserra@vallhebron.cat

Gloria Santaliestra

CONTACT

34 932746259; gloria.santaliestra@vhir.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: May 2, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-05

Locations

ES (1)