An interventional study of Biofeedback and Placebo in Rumination Disorders, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-14.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Treatment
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:
72 studies on the registry are indexed under Rumination Syndrome; 22 are open to participants now.
This study's enrollment of 32 is below the median of 62 across 63 interventional studies indexed under Rumination Syndrome.
Browse Rumination Syndrome studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Behavioral: Biofeedback
Dietary Supplement: Placebo
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.
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.
Number of rumination events after a challenge meal measured by electromyography
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.
Time frame: 4 weeks
Number of self perceived rumination events.
Number of rumination events measured by questionnaires administered daily for 10 days before and after treatment.
Time frame: 4 weeks
Abdominal discomfort.
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.
Time frame: 4 weeks
Number of self perceived rumination events 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.
Time frame: up to 6 months
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute