Cirrhosis, Liver
Conditions
Keywords
Cirrhosis；fecal Microbiota Transplantation
Brief summary
Patients with cirrhosis were recruitted and divided into cintrol group and FMT group. Patients in FMT group were carried by fecal microbiota transplantation, and biochemical indexes, intestinal flora and intestinal HIF expression were observed before and after FMT respectively.
Interventions
OTHERHealthy fecal bacteria liquid
Fecal bacteria liquid were obtained from healthy people by a feces processor, and perfused into the patient's intestine.
Sponsors
First Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of cirrhotic * aged 18-80 years. * must be able to cooperate with treatment
Exclusion criteria
* Patients with severe cardiac, pulmonary and renal dysfunction; * Patients with severe hypertension and cerebrovascular accidents; * Patients with liver cancer or active infection are in the active stage of hepatic encephalopathy or gastrointestinal bleeding; * Prothrombin activity ≤40%, platelet count \< 50\*10\^9/L; * Patients with intellectual and language disorders and mental disorders; * Probiotics with antibiotic and drug grade were used within 3 months prior to sampling; * There are prehepatic or posthepatic portal hypertension reasons; * Drug history: anticoagulant therapy, use of antiplatelet drugs, and current use of beta blockers, statins or interferon (IFN) treatment; * Peptic colon examination contraindications, such as intestinal perforation, intestinal obstruction, etc. * Other researchers believe that patients should not be included in the group.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| liver stiffness | Change from baseline liver stiffness at 12 months | liver stiffness in Kpa |
| blood ammonia | Change from baseline blood ammonia at 12 months | blood ammonia in umol/L |
| alanine aminotransferase | Change from baseline alanine aminotransferase at 12 months | alanine aminotransferase in U/L |
| aspartate aminotransferase | Change from baseline aspartate aminotransferase at 12 months | aspartate aminotransferase in U/L |
| gut microbiome | Change from baseline gut microbiome at 12 months | 16S RNA sequencing in gut microbiome |
| white blood cell | Change from baseline white blood cell at 12 months | white blood cell in /L |
| hemoglobin | Change from baseline hemoglobin at 12 months | hemoglobin in g/L |
| blood platelet | Change from baseline blood platelet at 12 months | blood platelet in/L |
| albumin | Change from baseline albumin at 12 months | albumin in g/L |
| blood glucose | Change from baseline blood glucose at 12 months | blood glucose in mmol/L |
| Serum creatinine | Change from baseline serum creatinine at 12 months | Serum creatinine in umol/L |
| direct bilirubin | Change from baseline direct bilirubin at 12 months | direct bilirubin in umol/L |
| indirect bilirubin | Change from baseline indirect bilirubin at 12 months | indirect bilirubin in umol/L |
| prothrombin time activity percentage | Change from baseline prothrombin time activity percentage at 12 months | prothrombin time activity percentage in % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of HIF-1α in intestine | Change from baseline HIF-1α expression in intestine at 12 months | Concentration of HIF-1α expression in intestine by western blot |
Contacts
Primary ContactYongping Chen, Prof
Outcome results
None listed