Effects of Vitamin D on Gut Microbiota, Intestinal Barrier in Patients With Diarrhea-predominant Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- gut microbiota
研究概览
简要总结
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disease. Evidence suggests that the concentration of serum VD is decreased in IBS patients, particularly in IBS-D. After giving a supplementation of VD, some symptoms of these patients were relieved to a certain degree. However, the specific mechanism still remains unclear.
详细描述
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disease, which is due to the gut microbiota disturbances, intestinal mucosal barrier dysfunction, and brain-gut axis dysfunction. Vitamin D (VD), a fat-soluble vitamin, has been found to be associated with gut microbiota, intestinal mucosal barrier and NLRP3 in inflammatory bowel disease, nonalcoholic fatty liver disease and other diseases. The concentration of serum VD is decreased in IBS patients, particularly in IBS-D. And the symptoms of IBS patients seems to be connected with the level of serum VD. After giving a supplementation of VD, some symptoms of these patients were relieved to a certain degree. However, the specific mechanism still remains unclear.We designed a study to figure out the effects of serum VD on gut microbiota, intestinal mucosal barrier and in patients with IBS-D.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •①IBS-D patients meeting the Roman IV diagnostic criteria: recurrent abdominal pain, averaging at least 1 day per week in the last 3 months, with 2 or more of the following: associated with defecation, accompanied by changes in defecation frequency, accompanied by changes in fecal properties or appearance. (Symptoms have been present for at least 6 months before diagnosis, and meet the above diagnostic criteria in the last 3 months; >1/4 (25%) stools were Bristol Stool Scale type 6 or 7, and <1/4 (25%) stools were Bristol Stool Scale type 1 or 2); ② The age ranged from 18 to 65.
排除标准
- •① History of other gastrointestinal diseases, such as inflammatory bowel disease, infection, cancer, abdominal radiation or surgery, hepatobiliary and pancreatic diseases; ② Taking vitamin D drugs, calcium, contraceptives, glucocorticoids, probiotics, antibiotics, antidepressants, etc.; ③ Pregnancy and lactation; ④ Diabetes mellitus, thyroid disease, osteoporosis, etc.; ⑤ Complicated with serious heart, liver, lung, kidney, blood, serious mental diseases and other systemic diseases; (6) Boston Intestinal Preparation Scale score <6; The cecum was not detected by endoscopy. ⑦ Unwilling to participate or unable to give informed consent.
结局指标
主要结局
gut microbiota
时间窗: 1 week before colonoscopy
Detect the fecal microbiome by 16S rRNA gene sequencing.
intestinal barrier
时间窗: During the colonoscopy
Detect the expressions of Z0-1, occludin in intestinal mucosa
次要结局
未报告次要终点