Fecal Calprotectin Levels in Patients With Fibromyalgia: A Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Fecal calprotectin levels
研究概览
简要总结
This study was designed to evaluate fecal calprotectin levels in patients with fibromyalgia syndrome. Fecal calprotectin levels from fibromyalgia patients with and without gastrointestinal symptoms as well as healthy controls will be measured and compared.
详细描述
Fecal calprotectin (FC) is a calcium and zinc binding protein that is present in neutrophil granulocytes and is detected in the stool samples from subjects with inflammatory bowel disease and similar organic gastrointestinal pathologies. Fibromyalgia is often accompanied by irritable bowel syndrome, which is a non-inflammatory, functional disorder of the gastrointestinal tract. Due to the chronic nature of the disease, fibromyalgia patients' new symptoms related to underlying gastrointestinal organic disease may be overlooked. In this study we aimed to assess the FC levels in fibromyalgia patients and healthy controls in order to detect a possible difference in FC levels between patients with and without gastrointestinal symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Groups 1 and 2: patients diagnosed as having Fibromyalgia syndrome according to American College of Rheumatology 2016 classification criteria (8). Group 3 will consist of healthy controls
- •Older than 18 years of age
排除标准
- •Presence of gastrointestinal symptoms starting after the age of
- •Presence of inflammatory rheumatological disorder
- •Presence of organic gastrointestinal disorder
- •History of fever, infective gastroenteritis, endoscopy or colonoscopy in the previous month
- •Family history of inflammatory bowel disease
- •Patients with alarm symptoms that required further investigation such as weight loss, nocturnal diarrhea, rectal bleeding
- •Illiteracy
结局指标
主要结局
Fecal calprotectin levels
时间窗: 1 day
Fecal calprotectin levels higher than 50 microgram/grams of feces will be considered positive
次要结局
- Correlation of fecal calprotectin levels with fibromyalgia disease parameters(1 day)
研究者
Ece Cinar
Principal investigator
Ege University