Treament of Rumination

NCT ID: NCT04167371

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-02
• Study Completion Date: 2022-02-01

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.

Conditions

Rumination Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Biofeedback

Group Type: EXPERIMENTAL

Biofeedback

Intervention Type: BEHAVIORAL

Three sessions by biofeedback will be performed during the first 3 weeks of the intervention period. In each session 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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Three sessions will be performed during the first 3 weeks of the intervention period. In each session abdominal and thoracic perimeter will be recorded but not shown to the patient; patients will take a pill of placebo containing 0.5 g glucose and no specific instructions will be provided. Patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.

Interventions

Biofeedback

Three sessions by biofeedback will be performed during the first 3 weeks of the intervention period. In each session 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.

Intervention Type: BEHAVIORAL

Placebo

Three sessions will be performed during the first 3 weeks of the intervention period. In each session abdominal and thoracic perimeter will be recorded but not shown to the patient; patients will take a pill of placebo containing 0.5 g glucose and no specific instructions will be provided. Patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Rumination syndrome

Exclusion Criteria

• Relevant organic diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Vall d'Hebron Research Institute

Barcelona, , Spain

Countries

Spain

Other Identifiers

PR(AG)373/2019

Identifier Type: -

Identifier Source: org_study_id