Fecal Microbiota Transplantation in Cirrhosis

Study Overview
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Brief Summary
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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.

Official Title
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The Study of HIF-1α in Cirrhosis by Fecal Microbiota Transplantation

Conditions
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Cirrhosis, Liver

Intervention / Treatment
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* Other: Healthy fecal bacteria liquid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT group<br>Patients were carried by fecal microbiota transplantation which described in detail that fecal bacteria are extracted from the faeces of healthy people and poured into the intestines of patients. | Other: Healthy fecal bacteria liquid<br>* Fecal bacteria liquid were obtained from healthy people by a feces processor, and perfused into the patient's intestine.<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood ammonia | blood ammonia in umol/L | Change from baseline blood ammonia at 12 months | 
| alanine aminotransferase | alanine aminotransferase in U/L | Change from baseline alanine aminotransferase at 12 months | 
| aspartate aminotransferase | aspartate aminotransferase in U/L | Change from baseline aspartate aminotransferase at 12 months | 
| gut microbiome | 16S RNA sequencing in gut microbiome | Change from baseline gut microbiome at 12 months | 
| white blood cell | white blood cell in /L | Change from baseline white blood cell at 12 months | 
| hemoglobin | hemoglobin in g/L | Change from baseline hemoglobin at 12 months | 
| blood platelet | blood platelet in/L | Change from baseline blood platelet at 12 months | 
| albumin | albumin in g/L | Change from baseline albumin at 12 months | 
| blood glucose | blood glucose in mmol/L | Change from baseline blood glucose at 12 months | 
| Serum creatinine | Serum creatinine in umol/L | Change from baseline serum creatinine at 12 months | 
| direct bilirubin | direct bilirubin in umol/L | Change from baseline direct bilirubin at 12 months | 
| indirect bilirubin | indirect bilirubin in umol/L | Change from baseline indirect bilirubin at 12 months | 
| prothrombin time activity percentage | prothrombin time activity percentage in % | Change from baseline prothrombin time activity percentage at 12 months | 
| liver stiffness | liver stiffness in Kpa | Change from baseline liver stiffness at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of HIF-1α in intestine | Concentration of HIF-1α expression in intestine by western blot | Change from baseline HIF-1α expression in intestine at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cirrhosis；fecal Microbiota Transplantation