The Role of Probiotics in Chronic Cholestasis to Prevent Gastrointestinal Diseases in Pediatric Patients in Cipto Mangunkusumo Hospital
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- fecal calprotectin
研究概览
简要总结
double blinded RCT (probiotics vs placebo) given to pediatric patients with chronic cholestasis for 4 weeks duration. baseline characteristics (antropometry, gastrointestinal symptoms, laboratory examinations) would be compared pre vs post treatment
详细描述
In mice model of cirrhosis and ascites, there is an increased intestinal permeability (leaky gut syndrome), subsequently leads to bacterial translocation. Bacterial translocation ultimately leads to bacterial overgrowth and increases associated morbidity, for instance, protracted diarrhea.
This RCT aims to administer probiotics product (lacto-B) in pediatric patients with chronic cholestasis (cholestasis > 4 weeks, evidenced from laboratory examination results).
method: double-blinded RCT
regimen: (identical, plain silver packaging, with code 0/1 --> revealed by 3rd party upon study completion)
intervention group: lacto-B 2 sachet per day for 4 weeks (28 days) each sachet of lacto-B contains: Viable Counts 1 x 107 CFU/g living bacteria in dual pH dependent release coated (Lactobacillus acidophilus, Bifidobacterium longum, Streptococcus thermophilus), Vitamin C 10 mg, Vitamin B1 0.5 mg, Vitamin B2 0.5 mg, Vitamin B6 0.5 mg, Niacin 2 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both placebo and probiotics have the exact same packaging. batch production numbers are printed, ended with either "0" or "1". code will be revealed by third party (production and packaging team) upon study completion (following data analysis)
入排标准
- 年龄范围
- 29 Days 至 215 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with chronic cholestasis (>4 weeks evidence of cholestasis from laboratory evidence)
- •patient/guardian give consent to participate
排除标准
- •immunocompromised
- •consumed antibiotic within 2 weeks prior to recruitment time
- •patient already consuming probiotic-added formula (any probiotic supplementation or formula milk with added probiotic)
结局指标
主要结局
fecal calprotectin
时间窗: 28th day of product consumption
fecal calprotectin measured using ELISA technique, reported in micrograms/gram
macroscopic fecal analysis
时间窗: 28th day of product consumption
consistency of stool according to Bristol stool chart
microscopic fecal erythrocyte count
时间窗: 28th day of product consumption
fecal erythrocyte count per high power field
microscopic fecal leukocyte count
时间窗: 28th day of product consumption
fecal leukocyte count per high power field
gut microbiota diversity
时间窗: 28th day of product consumption
PCR of gut microbiota diversity
presence of intestinal bacteria overgrowth
时间窗: 28th day of product consumption
measured using hydrogen breath test
次要结局
- incidence of diarrhea(day 1- day 28 of product consumption)
- antibiotic use(day1 - day 28 of product consumption)
- ALP(28th day of product consumption)
- albumin(28th day of product consumption)
- GGT(28th day of product consumption)
- ALT(28th day of product consumption)
- AST(28th day of product consumption)
- bilirubin level(28th day of product consumption)
研究者
dr. Fatima Safira Alatas, SpA(K), PhD
Pediatric gastrohepatoenterologist consultant, clinical professor
Indonesia University