Clinical trial NCT02214472: Treatment of Rumination by Biofeedback - a Randomized Controlled Trial
Official title: Valoración Objetiva y Tratamiento de la rumiación.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rumination Disorders
Keywords: Rumination síndrome
Regurgitation
Vomiting
Biofeedback
Electromyography
Abdominal accommodation
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Rumination syndrome

Exclusion Criteria:

* Relevant organic disease

Primary outcomes:
measure: Number of regurgitation episodes
timeFrame: 28 days
Secondary outcomes:
measure: Postprandial abdominal symptoms
timeFrame: 28 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
state: Catalunya
city: Barcelona
country: Spain
facility: Fernando Azpiroz
Study officials:
affiliation: Hospital Universitary vall d'Hebron
name: Fernando Azpiroz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Barba 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.