NCT02395484Unknown不适用
Species and Metagenome Analysis of Gut Microbiota in Chronic Constipation Patients
Jinling Hospital, China1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- taxonomic and functional characterization of gut microbiota
研究概览
简要总结
Constipation is a heterogeneous and multifactorial disease, influenced by a number of different genetic and environmental factors. By applying the standard two-stage GWAS strategy to design and carry out a metagenome-wide association study (MGWAS) to find the relationship between gut microbiota and constipation, to identify disease-associated metagenomic markers.
详细描述
This study is a two-stage case-control metagenome-wide association study (MGWAS) based on deep next-generation shotgun sequencing of DNA extracted from the stool samples from a total of 50 Chinese constipation patients and healthy controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
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
- •Chronic constipation according to Rome III criteria;
- •Age ≥ 18 years;
- •BMI: 18.5-25kg/m2;
排除标准
- •Bowel constipation due to innate factor (e.g. megacolon) or secondary interventions (e.g. drugs, endocrine, metabolic, neurologic or psychologic disorders);
- •History or evidence of gastrointestinal diseases (e.g. cancer, inflammatory bowel diseases);
- •Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section;
- •Previous proctological or perianal surgery;
- •Rectal prolapse and/or grade 3-4 internal hemorrhoids according to AGA classification;
- •A constipation condition meeting the Rome III criteria for IBS or functional abdominal pain syndrome;
- •Pregnant or breast-feeding women;
- •Infection with enteric pathogen;
- •Usage of probiotics, prebiotics, antibiotics or PPIs within the last month;
- •Smoking or alcohol addiction within the last 3 months;
- •Uncontrolled hepatic, renal, cardiovascular, respiratory or psychiatric disease;
- •Disease or therapy with drugs (e.g. antidepressants, opioid narcotic analgesics, anticholinergics, calcium antagonists, nitrates, antimuscarinics) that, in the opinion of the investigator, could affect intestinal transit and microbiota.
结局指标
主要结局
taxonomic and functional characterization of gut microbiota
时间窗: one year
次要结局
- Gut-microbiota-based constipation classification(one year)
- constipation-associated gut microbial markers(one year)
研究者
Jianfeng Gong
MD
Jinling Hospital, China
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Constipation, Gut Microbiome, and Microbial-derived Uremic Toxins From the Gut Microbiota in HD PatientsInflammationConstipationNCT04309019Tungs' Taichung Metroharbour Hospital61
Unknown
不适用
Using 16S rRNA Gene Sequencing Analysis Intestinal Microbiota in Constipation PatientsSlow Transit ConstipationNCT02984969Jinling Hospital, China20
已完成
不适用
Profiling the Variation of Microbiome Along the Intestinal Tract Based on Sampling Capsule EndoscopyHealthy Volunteers OnlyNCT06735196Changhai Hospital30
招募中
不适用
Natural History of Clostridioides Difficile InfectionClostridium Difficile InfectionHealth Care Associated InfectionNosocomial InfectionNCT04801862Hospital Universitario de Valme750
已完成
不适用
Advanced Metagenomic Analysis of Human Colonic Microbiota in Patients With Chronic GI DisordersColitis, UlcerativeColonic NeoplasmsIrritable Bowel SyndromeCrohn DiseaseNCT01099111King Fahad Medical City225