Synbiotics Interventions for Managing Cirrhosis and Its Complications

Cirrhosis, Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05687409
• Other study ID #: wuzhongwenzju
• Status: Completed
• Phase: Phase 4
• Start date: November 24, 2019
• Est. completion date: October 24, 2022

Study information

• Verified date: November 2022
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 24, 2022
• Est. primary completion date: May 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• ? 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. ? Under 90 years old.
• The patient or family member signs the informed consent form.

Exclusion Criteria:

• ? The CTP of liver cirrhosis was evaluated as grade C.
• Other types of cirrhosis such as primary biliary cirrhosis.
• Pregnancy status. ? 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. ? Patients and their families do not agree to sign the informed consent form. ? Under 18 years old or over 90 years old.

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• Entecavir 0.5 mg
Orally administered Entecavir 0.5 mg, once a day. For six months
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver CT to assess cirrhosis in 70 cirrhotic participants	Liver CT was used to evaluate the liver cirrhosis of 70 cirrhotic participants	Up to 11 months
Primary	Assessing the intestinal microbiota of 120 cirrhotic and healthy participants through fecal metagenomics	fecal metagenomics was used to assess the intestinal microbiota of participants.	Up to 12 months
Primary	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.	Up to 12 months