Synbiotics Interventions for Managing Cirrhosis and Its Complications

January 12, 2023 updated by: First Affiliated Hospital of Zhejiang University

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital, College of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A 10-g packet of lactulose oral solution and three capsules of probiotics +entecavir group

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

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.
Drug: Entecavir 0.5 mg
Orally administered Entecavir 0.5 mg, once a day. 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Up to 11 months
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.
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.
Time Frame: Up to 12 months
Metabolomics was used to assess the metabolites of the participants' intestinal microbiota.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • wuzhongwenzju

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

share date: within 6 months after project finish. Website: Resman. http://www.medresman.org.cn/pub/cn/proj/search.aspx

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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