NCT05687409

Synbiotics Interventions for Managing Cirrhosis and Its Complications

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Cirrhosis, Liver
• Metagonimiasis

Interventions

Type	Name	Description
DRUG	Entecavir 0.5 mg	Orally administered Entecavir 0.5 mg, once a day. For six months
DRUG	A 10-g packet of lactulose oral solution and three capsules of probiotics	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.
DIETARY_SUPPLEMENT	A 10-g packet of glucose oral solution and three capsules of starch	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.

Timeline

• Start date: 2019-11-24
• Primary completion: 2021-05-24
• Completion: 2022-10-24
• First posted: 2023-01-18
• Last updated: 2023-01-18

Locations

1 site across 1 country: China