Fecal Microbiota Transplantation in Cirrhosis

Not Applicable

• Conditions: Cirrhosis, Liver
• Interventions: Other: Healthy fecal bacteria liquid

• Registration Number: NCT04591522
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-10-11
• Last Update Submitted: 2020-10-11
• Study Start: 2020-10-15
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Clinical diagnosis of cirrhotic
• aged 18-80 years.
• must be able to cooperate with treatment

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMT group	Healthy fecal bacteria liquid	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.

Primary Outcome Measures

Name	Time	Method
white blood cell	Change from baseline white blood cell at 12 months	white blood cell in /L
albumin	Change from baseline albumin at 12 months	albumin in g/L
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
prothrombin time activity percentage	Change from baseline prothrombin time activity percentage at 12 months	prothrombin time activity percentage in %
hemoglobin	Change from baseline hemoglobin at 12 months	hemoglobin in g/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
blood platelet	Change from baseline blood platelet at 12 months	blood platelet in/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
liver stiffness	Change from baseline liver stiffness at 12 months	liver stiffness in Kpa

Secondary Outcome Measures

Name	Time	Method
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