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Completed

NCT Number: NCT02402946

Placebo-controlled, Randomized Trial of a Simplified Biofeedback Technique for the Treatment of Rumination

Rumination syndrome is characterized by effortless recurrent regurgitation of recently ingested food into the mouth, with consequent expulsión or re-chewing and swallowing. In a previous study we showed that rumination is produced by an unperceived, somatic response to food ingestión. After having identified the key mechanisms of rumination, we developed an original EMG guided biofeedback technique with specific targets for correction, based on EMG-guided control of abdomino-thoracic muscular activity, and in a pilot study we showed the potential effectivity of this treatment. In a subsequent study this technique was validated by a formal placebo-controlled, randomized trial. The current aim is to test the efficacy of a simplified biofeedback technique not requiring EMG-guided control.

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Key information

Conditions

Rumination Disorders Digestive System Diseases Feeding and Eating Disorders Gastrointestinal Diseases Mental Disorders Rumination Syndrome

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Vall d'Hebron, Barcelona, Catalonia, Spain

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About this study

Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG: in the biofeedback group, patients will be instructed to control muscle activity, whereas in the placebo group patients will not. In each patient 3 sessions will be performed over a 10-day period. Physiological (muscular activity by EMG) and clinical outcomes (number of rumination events by questionnaries administered daily for 10 days) will be measured before and after treatment.

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 disease

Treatment and study plan

Biofeedback

Behavioral

Placebo

Drug

Primary outcomes

  1. Number of regurgitation episodes

    Time frame: 28 days

Secondary outcomes

  1. Postprandial abdominal symptoms

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Valoración Objetiva y Tratamiento de la rumiación

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Mar 30, 2015
Registry last updated
Aug 9, 2019

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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