- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04167371
Treament of Rumination
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Barcelona, Spain, 08035
- Vall d'Hebron Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Rumination syndrome
Exclusion Criteria:
- Relevant organic diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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.
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of rumination events after a challenge meal measured by electromyography
Time Frame: 4 weeks
|
Rumination events will be identified by recording the activity of the thoraco abdominal muscles (intercostals, external oblique, internal oblique, upper rectus, lower rectus) by electromyography after a challenge meal.
The response to the meal will be measured before and after treatment.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of self perceived rumination events.
Time Frame: 4 weeks
|
Number of rumination events measured by questionnaires administered daily for 10 days before and after treatment.
|
4 weeks
|
Abdominal discomfort.
Time Frame: 4 weeks
|
Abdominal discomfort will be measured by scales graded from 0 (no discomfort) to 10 (severe discomfort) administered daily for 10 days before and after treatment.
|
4 weeks
|
Number of self perceived rumination events up to 6 months.
Time Frame: up to 6 months
|
Number of self perceived rumination events measured daily for 10 days using questionnaires at 1 month, 3 months and 6 months after treatment.
|
up to 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR(AG)373/2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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