Placebo-controlled, Randomized Trial of a Simplified Biofeedback Technique for the Treatment of Rumination

Rumination Disorders Clinical Trial

Official title:

Valoración Objetiva y Tratamiento de la rumiación

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402946
• Other study ID #: PR(AG)200/2011 ammendment
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rumination syndrome is characterized by effortless recurrent regurgitation of recently ingested food into the mouth, with consequent expulsión or re-chewing and swallowing. In a previous study we showed that rumination is produced by an unperceived, somatic response to food ingestión. After having identified the key mechanisms of rumination, we 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 we showed the potential effectivity of this treatment. In a subsequent study this technique was validated by a formal placebo-controlled, randomized trial. The current aim is to test the efficacy of a simplified biofeedback technique not requiring EMG-guided control.

Description:

Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG: in the biofeedback group, patients will be instructed to control muscle activity, whereas in the placebo group patients will not. 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 questionnaries administered daily for 10 days) will be measured before and after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Rumination syndrome

Exclusion Criteria:

• relevant organic disease

Related Conditions & MeSH terms

• Feeding and Eating Disorders of Childhood
• 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 Hepatol. 2015 Jan;13(1):100-6.e1. doi: 10.1016/j.cgh.2014.04.018. Epub 2014 Apr 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of regurgitation episodes		28 days
Secondary	Postprandial abdominal symptoms		28 days