NCT04167371

Treament of Rumination

Completed NA Last updated 14 February 2022

What this trial tests

NA trial testing Biofeedback in Rumination Disorders in 32 participants. Completed in 1 February 2022.

Timeline

2 December 2019

Primary endpoint
30 October 2020

1 February 2022

Quick facts

Lead sponsor	Hospital Universitari Vall d'Hebron Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	32
Start date	2 December 2019
Primary completion	30 October 2020
Estimated completion	1 February 2022
Sites	1 location across Spain

Drugs / interventions tested

• Biofeedback
• Placebo

Conditions studied

• Rumination Disorders — all drugs for Rumination Disorders →

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Who can join

Adults 18 to 80, any sex, with Rumination Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background. 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 we showed that rumination is produced by an unperceived, somatic response to food ingestion. We developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. In a randomized, placebo-controlled trial we demonstrated the superiority of biofeedback over placebo for the treatment of rumination. However, the technique is technically complex and unpractical.

Aim. To prove the efficacy of a simplified biofeedback technique for the treatment of rumination. Selection criteria. Rumination after meal ingestion. Intervention. Patients will be randomized into biofeedback in placebo groups. Three sessions of either biofeedback or placebo intervention will be performed after ingestion of a probe meal during the first 3 weeks of the 4 weeks intervention period.

Biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.

Placebo: abdominal and thoracic perimeter will be recorded but not shown to the patient and a pill of placebo containing 0.5 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.

Primary Outcome Measure:

Number of rumination events measured by electromyography in response to the challenge meal before and after treatment.

Secondary Outcome Measures:

* Number of self perceived rumination events measured by questionnaires administered daily for 10 days will before and after treatment.
* Associated abdominal symptom measured by questionnaires administered daily for 10 days before and after treatment.
* Follow up: number of self perceived rumination events measured at 1, 3 and 6 months after treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.