Treatment of Rumination by Biofeedback - a Randomized Controlled Trial

Rumination Disorders Clinical Trial

Official title:

Valoración Objetiva y Tratamiento de la rumiación.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02214472
• Other study ID #: PR(AG)200/2011
• Status: Completed
• Phase: N/A
• First received: August 6, 2014
• Last updated: November 9, 2015
• Start date: January 2013
• Est. completion date: April 2015

Study information

• Verified date: November 2015
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Rumination syndrome

Exclusion Criteria:

• Relevant organic disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rumination Disorders

Intervention

Behavioral:
• Biofeedback

Drug:
• Placebo

Locations

Country	Name	City	State
Spain	Fernando Azpiroz	Barcelona
Spain	University Hospital Vall d'Hebron	Barcelona	Catalunya

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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 Hepato — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of regurgitation episodes		28 days	No
Secondary	Postprandial abdominal symptoms		28 days	No