Fecal Microbiota Transplantation in Cirrhosis

Cirrhosis, Liver Clinical Trial

— FMT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04591522
• Other study ID #: Yongping_Chen
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2020
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: Yongping Chen, Prof
• Phone: +8613505777281
• Email: did[@]wzhospital.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis

Intervention

Other:
• Healthy fecal bacteria liquid
Fecal bacteria liquid were obtained from healthy people by a feces processor, and perfused into the patient's intestine.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Wenzhou Medical University

References & Publications (1)

Sung CM, Lin YF, Chen KF, Ke HM, Huang HY, Gong YN, Tsai WS, You JF, Lu MJ, Cheng HT, Lin CY, Kuo CJ, Tsai IJ, Hsieh SY. Predicting Clinical Outcomes of Cirrhosis Patients With Hepatic Encephalopathy From the Fecal Microbiome. Cell Mol Gastroenterol Hepat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood ammonia	blood ammonia in umol/L	Change from baseline blood ammonia at 12 months
Primary	alanine aminotransferase	alanine aminotransferase in U/L	Change from baseline alanine aminotransferase at 12 months
Primary	aspartate aminotransferase	aspartate aminotransferase in U/L	Change from baseline aspartate aminotransferase at 12 months
Primary	gut microbiome	16S RNA sequencing in gut microbiome	Change from baseline gut microbiome at 12 months
Primary	white blood cell	white blood cell in /L	Change from baseline white blood cell at 12 months
Primary	hemoglobin	hemoglobin in g/L	Change from baseline hemoglobin at 12 months
Primary	blood platelet	blood platelet in/L	Change from baseline blood platelet at 12 months
Primary	albumin	albumin in g/L	Change from baseline albumin at 12 months
Primary	blood glucose	blood glucose in mmol/L	Change from baseline blood glucose at 12 months
Primary	Serum creatinine	Serum creatinine in umol/L	Change from baseline serum creatinine at 12 months
Primary	direct bilirubin	direct bilirubin in umol/L	Change from baseline direct bilirubin at 12 months
Primary	indirect bilirubin	indirect bilirubin in umol/L	Change from baseline indirect bilirubin at 12 months
Primary	prothrombin time activity percentage	prothrombin time activity percentage in %	Change from baseline prothrombin time activity percentage at 12 months
Primary	liver stiffness	liver stiffness in Kpa	Change from baseline liver stiffness at 12 months
Secondary	Concentration of HIF-1a in intestine	Concentration of HIF-1a expression in intestine by western blot	Change from baseline HIF-1a expression in intestine at 12 months