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Completed

NCT Number: NCT05687409

Synbiotics Interventions for Managing Cirrhosis and Its Complications

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.

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Key information

Conditions

Cirrhosis, Liver Digestive System Diseases Fibrosis Helminthiasis Infections Liver Cirrhosis Liver Diseases Metagonimiasis Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trematode Infections

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

entecavir 0.5 mg

Drug

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

Drug

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 starch

Dietary 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.

Primary outcomes

  1. Liver CT to assess cirrhosis in 70 cirrhotic participants

    Time frame: Up to 11 months

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

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

    Time frame: Up to 12 months

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

  3. 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.

    Time frame: Up to 12 months

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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 18, 2023
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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