Synbiotics Interventions for Managing Cirrhosis and Its Complications

NCT ID: NCT05687409

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-24
• Study Completion Date: 2022-10-24

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.

Conditions

Cirrhosis, Liver; Metagonimiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Entecavir 0.5 mg

Intervention Type: 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

Intervention Type: 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+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.

Group Type: PLACEBO_COMPARATOR

Entecavir 0.5 mg

Intervention Type: DRUG

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

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

Intervention Type: 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.

Interventions

Entecavir 0.5 mg

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

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

References

Lu H, Zhu X, Wu L, Lou X, Pan X, Liu B, Zhang H, Zhu L, Li L, Wu Z. 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. Front Microbiol. 2023 Apr 26;14:1169811. doi: 10.3389/fmicb.2023.1169811. eCollection 2023.

Reference Type: DERIVED

PMID: 37180228 (View on PubMed)

Other Identifiers

wuzhongwenzju

Identifier Type: -

Identifier Source: org_study_id