Treatment of Rumination by Biofeedback - a Randomized Controlled Trial
Valoración Objetiva y Tratamiento de la rumiación.
1 other identifier
interventional
24
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 6, 2014
CompletedFirst Posted
Study publicly available on registry
August 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedNovember 10, 2015
November 1, 2015
1.7 years
August 6, 2014
November 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of regurgitation episodes
28 days
Secondary Outcomes (1)
Postprandial abdominal symptoms
28 days
Study Arms (2)
Biofeedback
EXPERIMENTALAbdomino-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.
Placebo medication
PLACEBO COMPARATORElectromyography will be recorded but not shown to the patients. Patients will take a pill of placebo.
Interventions
Eligibility Criteria
You may qualify if:
- Rumination syndrome
You may not qualify if:
- Relevant organic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Fernando Azpiroz
Barcelona, Barcelona, 08035, Spain
University Hospital Vall d'Hebron
Barcelona, Catalonia, 08035, Spain
Related Publications (2)
Barba E, Burri E, Accarino A, Malagelada C, Rodriguez-Urrutia A, Soldevilla A, Malagelada JR, Azpiroz F. Biofeedback-guided control of abdominothoracic muscular activity reduces regurgitation episodes in patients with rumination. Clin Gastroenterol Hepatol. 2015 Jan;13(1):100-6.e1. doi: 10.1016/j.cgh.2014.04.018. Epub 2014 Apr 24.
PMID: 24768808RESULTBarba E, Accarino A, Soldevilla A, Malagelada JR, Azpiroz F. Randomized, Placebo-Controlled Trial of Biofeedback for the Treatment of Rumination. Am J Gastroenterol. 2016 Jul;111(7):1007-13. doi: 10.1038/ajg.2016.197. Epub 2016 May 17.
PMID: 27185077DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fernando Azpiroz, MD
Hospital Universitary vall d'Hebron
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
August 6, 2014
First Posted
August 12, 2014
Study Start
January 1, 2013
Primary Completion
October 1, 2014
Study Completion
April 1, 2015
Last Updated
November 10, 2015
Record last verified: 2015-11