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NCT Number: NCT06971354

Treatment of Rumination

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vall d'Hebron Research Institute

Barcelona, 08035, Spain

Location status: Recruiting

Location contact

Jordi Serra, M.D.

CONTACT

[email protected]

34 93 274 6259

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Rumination syndrome

Exclusion criteria

  • Relevant organic diseases

Treatment and study plan

Biofeedback

Behavioral

Three sessions of biofeedback before and after a standardized meal.

Placebo

Dietary Supplement

Three sessions of placebo followed by standardized meal.

Primary outcomes

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

    Time frame: 4 weeks

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

Secondary outcomes

  1. Number of self perceived rumination events

    Time frame: 4 weeks

    Number of rumination events measured by questionnaires administered daily for 7 days before and at the end of treatment.

  2. Number of rumination events

    Time frame: 1 month

    Number of rumination events measured by questionnaires administered daily for 7 days, 1 month after treatment.

  3. Number of rumination events

    Time frame: 3 months

    Number of rumination events measured by questionnaires administered daily for 7 days, 3 months after treatment.

  4. Number of rumination events

    Time frame: 6 months

    Number of rumination events measured by questionnaires administered daily for 7 days, 6 months after treatment.

  5. Quantity of meal regurgitated

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gloria Santaliestra

CONTACT

[email protected]

34 932746259

Jordi Serra, M.D.

CONTACT

[email protected]

34 93 274 6259

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Tratamiento de la rumiación: Estudio Aleatorizado, Paralelo y Controlado

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 14, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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