Synbiotics Interventions for Managing Cirrhosis and Its Complications

First Affiliated Hospital of Zhejiang University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Cirrhosis, Liver Metagonimiasis

Interventions

A 10-g packet of lactulose oral solution and three capsules of probioticsDRUG

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. For six months.

A 10-g packet of glucose oral solution and three capsules of starchDIETARY_SUPPLEMENT

A 10-g packet of glucose oral solution and three capsules of starch. Participants orally administered the contents three times daily after meals. For six months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Liver CT to assess cirrhosis in 70 cirrhotic participants

Liver CT was used to evaluate the liver cirrhosis of 70 cirrhotic participants

Time frame: Up to 11 months

Assessing the intestinal microbiota of 120 cirrhotic and healthy participants through fecal metagenomics

fecal metagenomics was used to assess the intestinal microbiota of participants.

Time frame: Up to 12 months

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.

Metabolomics was used to assess the metabolites of the participants' intestinal microbiota.