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OpenTrials
Completed

NCT Number: NCT02214472

Treatment of Rumination by Biofeedback - a Randomized Controlled Trial

Rumination syndrome is characterized by effortless recurrent regurgitation of recently ingested food into the mouth, with consequent expulsion or re-chewing and swallowing. In a previous study the investigators showed that rumination is produced by an unperceived, somatic response to food ingestion.

After having identified the key mechanisms of rumination, the investigators 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 the investigators showed the potential effectivity of this treatment. The current aim is to validate this previous uncontrolled observation by a formal placebo-controlled, randomized trial.

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Key information

Conditions

Rumination Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Feeding and Eating Disorders Gastroesophageal Reflux Gastrointestinal Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Rumination Syndrome Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fernando Azpiroz, Barcelona, Spain

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About this study

Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG and the signal displayed on a monitor and front in the patients: in the biofeedback group, patients will be instructed to control muscle activity, whereas in the placebo group patients will receive a pill of placebo. 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 questionnaires administered daily for 10 days) will be measured before and after treatment.

Who can participate

Healthy volunteers accepted: Yes

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
2013
Primary completion
2014
Study completion
2015
First posted
Aug 12, 2014
Registry last updated
Nov 10, 2015

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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