Treament of Rumination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of rumination events after a challenge meal measured by electromyography
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rumination syndrome
排除标准
- •Relevant organic diseases
研究组 & 干预措施
Biofeedback
干预措施: Biofeedback (Behavioral)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Number of rumination events after a challenge meal measured by electromyography
时间窗: 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.
次要结局
- Abdominal discomfort.(4 weeks)
- Number of self perceived rumination events.(4 weeks)
- Number of self perceived rumination events up to 6 months.(up to 6 months)