Spectrum of Gastrointestinal Microbiota in Patients With IBS-D Before and After Treatment With VSL#3.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement of symptoms after modulation of gut microbiota with probiotic, VSL#3
研究概览
简要总结
Aim
To compare changes in gut microbiota of IBS patients and healthy controls using next generation sequencing method like Illumina sequencing based on 16S rDNA profiling.
The major objectives of the study are:
To characterize type of bacterial species and compare diversity of the host's gut microbiota in 20 Irritable bowel syndrome (IBS) patients with 16 healthy controls (HCs) using high through put culture-independent method like Illumina sequencing.
To study modulation of gut microbiota profile after treatment with probiotics (VSL #3) for 8 weeks.
To study the improvement of symptoms after modulation of gut microbiota with probiotics (VSL #3) for more than 8 weeks.
详细描述
Introduction
The role of the commensal flora in many disease states, including irritable bowel syndrome, inflammatory bowel disease, and even obesity, is now accepted and will undoubtedly lead to new therapeutic strategies. The recently NIH-initiated Human Microbiome Project will allow better understanding of the role of this complex intestinal community in human health and disease. On the clinical side, we are exploring the more common pathogenic bacterial strains in Irritable bowel syndrome patients and use of probiotics in this functional gastrointestinal disease. We are taking support from Genotypic institute, Bangalore for Illumina sequencing facility.
Asian Institute of Gastroenterology, the parent institution, is a 200 bed tertiary care referral hospital providing services to patients with GI diseases, with a daily attendance of 400 out-patients and 200 in-patients. The long term goals of the investigators, involving basic researchers and clinicians, include development of technological resources and applications of biotechnology for use in clinical trials to improve survival rates of patients with GI diseases. The major volume of the outpatient cases comprise of patients with irritable bowel syndrome. Altered GI microbiota may contribute to IBS symptoms and studying dysbiosis in gut microbiota is an important to develop therapy for IBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients satisfying Rome III Criteria
排除标准
- •Antimicrobial medication during last 2 months
- •Probiotics medication during last 2 months
- •Pregnant or lactating patients
- •Previous major or complicated abdominal surgery
- •Positive test for HIV, HBV or HCV
研究组 & 干预措施
VSL#3
Patients with IBS-D as per ROME III
干预措施: VSL#3 (Drug)
结局指标
主要结局
Improvement of symptoms after modulation of gut microbiota with probiotic, VSL#3
时间窗: 8 wks
To study modulation of gut microbiota profile after treatment with probiotics (VSL #3) for 8 weeks.
次要结局
- Comparison of GI microbiota before and after treatment(8 wks)
研究者
Pratap Nitesh
Consultant Gastroenterologist
Asian Institute of Gastroenterology, India
