A Prospective Exploratory Study on the Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Comparison of the Phase Angle Between IBS Patients and Healthy Individuals
研究概览
简要总结
The study aim is to investigate the Bio-electrical Impedance (BIA) parameters in general, and phase angle (PhA) in particular in Irritable bowel syndrome (IBS) patients and to compare these with values from healthy controls, while assessing the relationship with other confounding parameters in IBS: psychological parameters, physical activity, dietary pattern (with special interest in FODMAP intake). In a second phase, the evolution of the BIA parameters will be analyzed according to response to therapy.
详细描述
The role and significance of bio-electrical impedance analysis (BIA) has not been studied in IBS. Therefore, The investigators designed this exploratory study to assess its potential role in the diagnosis and follow-up of treatment in IBS. The study aim is to investigate the BIA parameters in general, and PhA in particular in IBS patients and to compare these with values from healthy controls, while assessing the relationship with other confounding parameters in IBS: psychological parameters, physical activity, dietary pattern (with special interest in FODMAP intake). In a second phase, the evolution of the BIA parameters will be analyzed according to response to therapy.
The primary objective is to compare the BIA parameters including PhA between IBS and healthy individuals.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 - 75 years;
- •Fulfilling the ROME IV criteria for IBS (only for patients);
排除标准
- •Clinical suspicion of an organic disorder different from IBS (patients can be included when this disorder had been excluded);
- •Known inflammatory bowel disorder;
- •Known major intestinal motility disorder;
- •Alcohol (defined as more than 14 U per week) or other substance abuse;
- •Active psychiatric disorder;
- •Known systemic or auto-immune disorder with implication for the GI system;
- •Prior abdominal surgery (with the exception of cholecystectomy or ap-pendectomy);
- •Any prior diagnosis of cancer other than basocellular carcinoma;
- •Current chemotherapy;
- •History of gastro-enteritis in the past 12 weeks;
- •Dietary supplements unless taken at a stable dose for more than 12 weeks;
- •Treatment with neuromodulators (one neuromodulator taken at a sta-ble dose for more than 12 weeks is allowed);
- •Pregnancy.
结局指标
主要结局
Comparison of the Phase Angle Between IBS Patients and Healthy Individuals
时间窗: The phase angle will be assessed through study completion, an average 6 months
Bio-electrical Impedance Analysis will be performed by trained personnel. BIA will be performed after fasting for at least 6 hours. Subjects should refrain from intensive physical activity the day be-fore the measurement. For women, measurements will be performed outside menstruating periods. Subjects will lay down on an examination couch with bare feet. Any jewelry will be removed. Reactance and resistance will be obtained. Phase angle will be calculated according to the formula: PhA (°) = (reactance/ resistance° x (180°/π).
Comparison of the Percentage of Total Body Water Between IBS Patients and Healthy Individuals
时间窗: The body composition will be assessed through study completion, an average 6 months
percentage of total body water will be calculated using the measurements obtained during the BIA analysis.
Comparison of the Muscle Mass Between IBS Patients and Healthy Individuals
时间窗: the muscle mass will be assessed through study completion, an average 6 months
The muscle mass will be calculated using the measurements obtained during the BIA analysis.
Comparison of the Percentage of Body Fat Between IBS Patients and Healthy Individuals
时间窗: the percentage of body fat will be assessed through study completion, an average 6 months
percentage of body fat will be calculated using the measurements obtained during the BIA analysis.
次要结局
未报告次要终点