Fecal Microbiota Transplantation in Cirrhosis (FMT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Cirrhosis, Liver
• Intervention / Treatment: Other: Healthy fecal bacteria liquid

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control group
EXPERIMENTAL: FMT group; 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; Fecal bacteria liquid were obtained from healthy people by a feces processor, and perfused into the patient's intestine.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: yongping Chen, Prof, First Affiliated Hospital of Wenzhou Medical University

Publications and helpful links

General Publications

• 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 Hepatol. 2019;8(2):301-318.e2. doi: 10.1016/j.jcmgh.2019.04.008. Epub 2019 Apr 18.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 15, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: October 11, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Cirrhosis；fecal Microbiota Transplantation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: Yongping_Chen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No