Synbiotics Interventions for Managing Cirrhosis and Its Complications

NCT05687409 | Completed Phase 4

• 1 other identifier: wuzhongwenzju
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Cirrhosis, Liver; Synbiotics

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

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

EXPERIMENTAL

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; Drug: 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+entecavir group

PLACEBO COMPARATOR

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; Dietary Supplement: A 10-g packet of glucose oral solution and three capsules of starch

Interventions

Entecavir 0.5 mg 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+entecavir group; A 10-g packet of lactulose oral solution and three capsules of probiotics +entecavir group

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 lactulose oral solution and three capsules of probiotics +entecavir group

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.

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 37180228 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Trematode Infections

Interventions

entecavir; Probiotics; Starch

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: January 18, 2023
• Study Start: November 24, 2019
• Primary Completion: May 24, 2021
• Study Completion: October 24, 2022
• Last Updated: January 18, 2023

Record last verified: 2022-11

Locations

CN (1)