Alterations in the Intestinal Microbiome and Metabolic Profile of Patients With Cirrhosis Supplemented With Lactulose, Clostridium Butyricum, and Bifidobacterium Longum Infantis: a Randomized Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Assessing the intestinal microbiota of 120 cirrhotic and healthy participants through fecal metagenomics
研究概览
简要总结
Background Liver cirrhosis is commonly accompanied by intestinal dysbiosis and metabolic defects. Many clinical trials have shown microbiota-targeting strategies represent promising interventions for managing cirrhosis and its complications. However, the influences of the intestinal metagenomes and metabolic profiles of patients have not been fully elucidated.
Methods administered lactulose, Clostridium butyricum, and Bifidobacterium longum infantis as a synbiotic and used shotgun metagenomics and non-targeted metabolomics to characterize the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •① Hepatitis B cirrhosis was diagnosed by clinical biochemistry and imaging.
- •CTP rating is a-b.
- •There was a previous liver cirrhosis complication, including ascites, spontaneous peritonitis, massive gastrointestinal bleeding, liver coma, etc.
- •Over 18 years old. ⑤ Under 90 years old.
- •The patient or family member signs the informed consent form.
排除标准
- •① The CTP of liver cirrhosis was evaluated as grade C.
- •Other types of cirrhosis such as primary biliary cirrhosis.
- •Pregnancy status. ④ Have a history of diabetes, renal insufficiency, gastrointestinal surgery, etc.
- •Antibiotics, PPI preparations and microecological preparations (including yogurt) have been used in the past 8 weeks.
- •Have a history of narcotic drug abuse, drug abuse, or mental illness. ⑦ Patients and their families do not agree to sign the informed consent form. ⑧ Under 18 years old or over 90 years old.
研究组 & 干预措施
A 10-g packet of lactulose oral solution and three capsules of probiotics +entecavir group
10-g packet of lactulose oral solution and three capsules of probiotics +entecavir group:Adults with histologically confirmed stable cirrhosis and BMI < 25 kg m-2 were enrolled and assigned to receive boxes labeled A or B: one for the synbiotic, including a 10-g packet of lactulose oral solution and three capsules of probiotics (each containing > 4.2×106 CFU Clostridium butyricum and > 4.2×105 CFU Bifidobacterium longum infantis). Participants orally administered the contents three times daily after meals.
Entecavir 5mg, once a day. All of the above lasted for six months.
干预措施: Entecavir 0.5 mg (Drug)
A 10-g packet of lactulose oral solution and three capsules of probiotics +entecavir group
10-g packet of lactulose oral solution and three capsules of probiotics +entecavir group:Adults with histologically confirmed stable cirrhosis and BMI < 25 kg m-2 were enrolled and assigned to receive boxes labeled A or B: one for the synbiotic, including a 10-g packet of lactulose oral solution and three capsules of probiotics (each containing > 4.2×106 CFU Clostridium butyricum and > 4.2×105 CFU Bifidobacterium longum infantis). Participants orally administered the contents three times daily after meals.
Entecavir 5mg, once a day. All of the above lasted for six months.
干预措施: A 10-g packet of lactulose oral solution and three capsules of probiotics (Drug)
A 10-g packet of glucose oral solution and three capsules of starch+entecavir group
A 10-g packet of glucose oral solution and three capsules of starch+entecavir group:Adults with histologically confirmed stable cirrhosis and BMI < 25 kg m-2 were enrolled and assigned to receive boxes labeled A or B: one for the synbiotic, including a 10-g packet of lactulose oral solution and three capsules of probiotics (each containing > 4.2×106 CFU Clostridium butyricum and > 4.2×105 CFU Bifidobacterium longum infantis). Participants orally administered the contents three times daily after meals.
Entecavir 5mg, once a day. All of the above lasted for six months.
干预措施: Entecavir 0.5 mg (Drug)
A 10-g packet of glucose oral solution and three capsules of starch+entecavir group
A 10-g packet of glucose oral solution and three capsules of starch+entecavir group:Adults with histologically confirmed stable cirrhosis and BMI < 25 kg m-2 were enrolled and assigned to receive boxes labeled A or B: one for the synbiotic, including a 10-g packet of lactulose oral solution and three capsules of probiotics (each containing > 4.2×106 CFU Clostridium butyricum and > 4.2×105 CFU Bifidobacterium longum infantis). Participants orally administered the contents three times daily after meals.
Entecavir 5mg, once a day. All of the above lasted for six months.
干预措施: A 10-g packet of glucose oral solution and three capsules of starch (Dietary Supplement)
结局指标
主要结局
Assessing the intestinal microbiota of 120 cirrhotic and healthy participants through fecal metagenomics
时间窗: Up to 12 months
fecal metagenomics was used to assess the intestinal microbiota of participants.
Liver CT to assess cirrhosis in 70 cirrhotic participants
时间窗: Up to 11 months
Liver CT was used to evaluate the liver cirrhosis of 70 cirrhotic participants
Metabolomics to assess the metabolites of the 120 cirrhotic and healthy participants' intestinal microbiota including polyketides(Casimiroedine μmol/L),Benzenoids(Olmesartan μmol/L),Organoheterocyclic compounds(Amlexanox μmol/L) and etc.
时间窗: Up to 12 months
Metabolomics was used to assess the metabolites of the participants' intestinal microbiota.
次要结局
未报告次要终点