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Synbiotics Interventions for Managing Cirrhosis and Its Complications

Primary Purpose

Cirrhosis, Liver, Metagonimiasis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Entecavir 0.5 mg
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
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis, Liver focused on measuring Cirrhosis, Liver, Synbiotics

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

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

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

Arm 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.

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.

Outcomes

Primary Outcome Measures

Liver CT to assess cirrhosis in 70 cirrhotic participants
Liver CT was used to evaluate the liver cirrhosis of 70 cirrhotic participants
Assessing the intestinal microbiota of 120 cirrhotic and healthy participants through fecal metagenomics
fecal metagenomics was used to assess the intestinal microbiota of participants.
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.

Secondary Outcome Measures

Full Information

First Posted
November 25, 2022
Last Updated
January 12, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05687409
Brief Title
Synbiotics Interventions for Managing Cirrhosis and Its Complications
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 24, 2019 (Actual)
Primary Completion Date
May 24, 2021 (Actual)
Study Completion Date
October 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver, Metagonimiasis
Keywords
Cirrhosis, Liver, Synbiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A 10-g packet of lactulose oral solution and three capsules of probiotics +entecavir group
Arm Type
Experimental
Arm 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.
Arm Title
A 10-g packet of glucose oral solution and three capsules of starch+entecavir group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Entecavir 0.5 mg
Intervention Description
Orally administered Entecavir 0.5 mg, once a day. For six months
Intervention Type
Drug
Intervention Name(s)
A 10-g packet of lactulose oral solution and three capsules of probiotics
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
A 10-g packet of glucose oral solution and three capsules of starch
Intervention Description
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 Outcome Measure Information:
Title
Liver CT to assess cirrhosis in 70 cirrhotic participants
Description
Liver CT was used to evaluate the liver cirrhosis of 70 cirrhotic participants
Time Frame
Up to 11 months
Title
Assessing the intestinal microbiota of 120 cirrhotic and healthy participants through fecal metagenomics
Description
fecal metagenomics was used to assess the intestinal microbiota of participants.
Time Frame
Up to 12 months
Title
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.
Description
Metabolomics was used to assess the metabolites of the participants' intestinal microbiota.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
share date: within 6 months after project finish. Website: Resman. http://www.medresman.org.cn/pub/cn/proj/search.aspx

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Synbiotics Interventions for Managing Cirrhosis and Its Complications

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