Synbiotics Interventions for Managing Cirrhosis and Its Complications

Zhejiang University

Status and phase: Completed; Phase 4

Conditions: Cirrhosis, Liver; Metagonimiasis

Treatments: Drug: A 10-g packet of lactulose oral solution and three capsules of probiotics; Dietary Supplement: A 10-g packet of glucose oral solution and three capsules of starch; Drug: Entecavir 0.5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05687409

wuzhongwenzju

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups, including a placebo group

A 10-g packet of lactulose oral solution and three capsules of probiotics +entecavir group

Experimental group

Description:

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.

Treatment:

Drug: Entecavir 0.5 mg

Drug: A 10-g packet of lactulose oral solution and three capsules of probiotics

A 10-g packet of glucose oral solution and three capsules of starch+entecavir group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Entecavir 0.5 mg

Dietary Supplement: A 10-g packet of glucose oral solution and three capsules of starch