CTRI/2020/12/029888已完成3 期
status and effect of pancreatic enzyme replacement therapy on gut microbiota and resting energy expenditure in patients with chronic pancreatitis
ICMR1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年3月11日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- This section would assess the status effect of following parameters in patients with chronic pancreatitis on :
研究概览
简要总结
This is is an interventional study. we will see the status of and effect of pancreatic enzyme replacement therapy on gut microbiota and resting energy expenditure in patients with chronic pancreatitis .
This study would assess the status of following parameters in patients with chronic pancreatitis versus healthy controls:- Gut microbiota
- Resting energy expenditure
- Levels of inflammatory cytokines
- Small intestinal bacterial over growth
- Body composition
- Quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •patients : 1.Idiopathic chronic pancreatitis 2.With or without pancreatic exocrine insufficiency 3.Participants giving the consent Healthy Controls: 1.Relative of the patient 2.In good general health with no co morbidities(diabetes, IBD, IBS etc) 3.No pregnancy 4.No calorie restriction or other special diets 5.No known allergy 6.Not on medical treatment influencing intestinal function 7.No alcohol ( intake more than 2 pegs a day) 8.No smoking.
排除标准
- •1.Concomitant medical disorder which are supposed to influence the gut microbiota like HIV, any malignancy, inflammatory bowel disease, irritable bowel syndrome, gastroenteritis, liver disease.
- •2.Pregnancy 3.Medical treatment influencing intestinal function 4.Subjects received antibiotics in last 3 months 5.Patients who are taking proton pump inhibitor 6.Chronic pancreatitis with another complication( symptomatic pseudocyst or GI bleed) 7.Severe pain score:16 or more.
结局指标
主要结局
This section would assess the status effect of following parameters in patients with chronic pancreatitis on :
时间窗: 0 month and 3 months
1.Gut Microbiota
时间窗: 0 month and 3 months
2.Resting energy expenditure
时间窗: 0 month and 3 months
次要结局
- To determine the effect of 3 months pancreatic enzyme replacement therapy in patients with chronic pancreatitis with pancreatic exocrine insufficiency on:(a)Levels of inflammatory cytokines)
研究者
研究点 (1)
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