Clinical Trial 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.
