A Phase 4 interventional study of Entecavir 0.5 mg and A 10-g packet of lactulose oral solution and three capsules of probiotics in Cirrhosis, Liver and Metagonimiasis, sponsored by First Affiliated Hospital of Zhejiang University. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by First Affiliated Hospital of Zhejiang University · Phase 4, Interventional, and Treatment
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 120 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
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: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
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 (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. Participants orally administered the contents three times daily after meals. For six months.
Liver CT to assess cirrhosis in 70 cirrhotic participants
Liver CT was used to evaluate the liver cirrhosis of 70 cirrhotic participants
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 months
Plan to share: Undecided — share date: within 6 months after project finish. Website: Resman. http://www.medresman.org.cn/pub/cn/proj/search.aspx
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Zhejiang University