Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir 0.5 mg | Drug | Orally administered Entecavir 0.5 mg, once a day. For six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37180228 | Derived | 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. |
Not provided
Not provided
share date: within 6 months after project finish. Website: Resman. http://www.medresman.org.cn/pub/cn/proj/search.aspx
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 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. |
|
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D014201 | Trematode Infections |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C413685 | entecavir |
| D019936 | Probiotics |
| D013213 | Starch |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
Not provided
Not provided