Clinical trial NCT04167371: Treament of Rumination
Official title: Treament of Rumination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rumination Disorders
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Rumination syndrome

Exclusion Criteria:

* Relevant organic diseases

Primary outcomes:
measure: Number of rumination events after a challenge meal measured by electromyography
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of self perceived rumination events.
timeFrame: 4 weeks
measure: Abdominal discomfort.
timeFrame: 4 weeks
measure: Number of self perceived rumination events up to 6 months.
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron Research Institute
Study officials:
References: