Analysis of Differences in Small Intestinal Microbiota Structure and Metabolites Between Patients With Irritable Bowel Syndrome and Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Identify the specific differences in the core architecture of the small intestinal microbiota between IBS patients and healthy individuals.
研究概览
简要总结
Irritable Bowel Syndrome (IBS) is a common functional bowel disorder with complex and not yet fully elucidated pathophysiological mechanisms. Recent research suggests that gut microbiota dysbiosis, particularly small intestinal bacterial overgrowth (SIBO), may play a key role in the generation of IBS symptoms. However, the vast majority of current studies have focused on fecal samples, which primarily reflect the colonic microbiota. The small intestinal microbiota, which is directly involved in nutrient digestion and absorption and more prone to dysbiosis, remains understudied due to the challenges in obtaining samples.
详细描述
This study aims to utilize intestinal sampling capsules to directly collect small intestinal fluid samples from both IBS patients and healthy controls. The community structure, diversity, and compositional differences of the small intestinal microbiota will be analyzed using 16S rRNA gene sequencing and metagenomic sequencing technologies, while the metabolic profiles of the small intestinal fluid will be detected via untargeted metabolomics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Experimental Group： Aged 18-65 years, male or female. Meets the Rome IV diagnostic criteria for IBS The absence of organic gastrointestinal disease that could explain the symptoms.
- •Provides informed consent and voluntarily signs the informed consent form. Control Group： Age and sex-matched to the IBS patient group. No history of chronic digestive diseases or current gastrointestinal symptoms. Has not used antibiotics, proton pump inhibitors, probiotics, or other medications known to affect gut microbiota within the past month.
- •Provides informed consent and voluntarily signs the informed consent form.
排除标准
- •History of gastrointestinal surgery (excluding appendectomy). Presence of concomitant organic gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease, gastrointestinal tumors).
- •Presence of severe concomitant cardiac, hepatic, renal, endocrine, hematologic, or neurological diseases.
- •Long-term use of medications known to affect gastrointestinal motility (e.g., opioids).
- •Pregnancy, lactation, or women planning a pregnancy. Conditions contraindicating the use of capsule endoscopy, such as dysphagia, or known gastrointestinal strictures, diverticula, or obstruction.
- •Any other condition deemed by the investigator as unsuitable for participation in the study.
结局指标
主要结局
Identify the specific differences in the core architecture of the small intestinal microbiota between IBS patients and healthy individuals.
时间窗: 6 Months
Intestinal content samples from different regions were collected from IBS patients and healthy subjects using smart enteric-coated sampling capsules. These samples subsequently underwent 16S rRNA gene sequencing and metagenomic sequencing to analyze microbial composition, alongside untargeted metabolomics to detect metabolic differences. The regional variations in both the microbiome and metabolome were then analyzed in the IBS cohort.
次要结局
未报告次要终点