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Treatment of Rumination by Biofeedback - a Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214472
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Rumination Disorders Behavioral: Biofeedback Drug: Placebo Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Valoración Objetiva y Tratamiento de la rumiación.
Study Start Date : January 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biofeedback
Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG and the signal will be displayed on a monitor in front of the patients; in the biofeedback group, patients will be instructed to control muscle activity.
Behavioral: Biofeedback
Placebo Comparator: Placebo medication
Electromyography will be recorded but not shown to the patients. Patients will take a pill of placebo.
Drug: Placebo



Primary Outcome Measures :
  1. Number of regurgitation episodes [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Postprandial abdominal symptoms [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Rumination syndrome

Exclusion Criteria:

  • Relevant organic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214472


Locations
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Spain
University Hospital Vall d'Hebron
Barcelona, Catalunya, Spain, 08035
Fernando Azpiroz
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Fernando Azpiroz, MD Hospital Universitary vall d'Hebron

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02214472    
Other Study ID Numbers: PR(AG)200/2011
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Rumination síndrome
Regurgitation
Vomiting
Biofeedback
Electromyography
Abdominal accommodation
Additional relevant MeSH terms:
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Feeding and Eating Disorders of Childhood
Feeding and Eating Disorders
Mental Disorders