Role of Abdominothoracic Muscular Activity on Symptoms of Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Postprandial fullness
研究概览
简要总结
Background. Patients with functional dyspepsia report symptoms after eating without detectable cause. A recent proof-of-concept study demonstrated that in healthy subjects, the activity of the abdominal walls influences perception of digestive sensations, specifically, intentional abdominal distension (by a maneuver of diaphragmatic contraction) increased bloating sensation in response to a probe meal.
Aim. To determine the role of the abdominothoracic muscular activity on symptoms of functional dyspepsia.
Design. Parallel study in dyspeptic patients who have an abnormal somatic response to a probe meal (experimental group), and patients who do not (control group), comparing the effect of abdominophrenic biofeedback on dyspeptic symptoms. The probe meal will consist in stepwise ingestion of a comfort meal (hot ham and cheese sandwich plus orange juice) up to maximal satiation.
Intervention. A standard biofeedback technique (3 sessions over a 4-week period) directed at controlling the muscular activity (postural tone) of the abdominal walls, will serve as active intervention in the experimental group, and as a sham intervention in the control (active comparator) group.
The study outcomes will be measured before, immediately after and at 6 months after biofeedback: 1) Clinical symptoms measured by scales during 7 consecutive days. 2) Responses to the probe meal: (a) sensations measured by scales; (b) changes in girth by adaptive belts; (c) diaphragmatic position by abdominal ultrasound.
Relevance. The identification of a pathophysiological mechanism of dyspeptic symptoms could serve as an objective marker for diagnosis and as a target for the development of mechanistic treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
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
- 是
入选标准
- •Rome IV Criteria for functional dyspepsia
排除标准
- •organic gastrointestinal diseases
- •history of anosmia and ageusia
- •alcohol abuse
- •eating disorders
- •Age- and-sex-matched healthy subjects will be included in parallel to the 30 first patients, to determine the normal values of the response to the probe meal. Healthy subjects will not undergo the intervention.
结局指标
主要结局
Postprandial fullness
时间窗: 7 days
Change in postprandial fullness (measured on daily postprandial fullness scales graded from 0, i.e., not at all, to 10, i.e., extremely severe) during 7 consecutive days before and immediately after intervention.
次要结局
- Tolerance of a probe meal(60 minutes)
- Abdominal distension in response to a probe meal(60 minutes)
- Postprandial fullness after a probe meal(60 minutes)
- Digestive well-being after a probe meal(60 minutes)
- Diaphragmatic response to a probe meal(60 minutes)