FMT: Fecal Microbiota Transplantation in Cirrhosis

Sponsor

First Affiliated Hospital of Wenzhou Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04591522

Collaborator

(none)

100

Enrollment

Arms

20.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis, Liver	Other: Healthy fecal bacteria liquid	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 15, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: control group

Arm

Intervention/Treatment

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.

No Intervention: control group

Outcome Measures

Primary Outcome Measures

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 %
liver stiffness [Change from baseline liver stiffness at 12 months]
liver stiffness in Kpa

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

First Affiliated Hospital of Wenzhou Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital of Wenzhou Medical University

ClinicalTrials.gov Identifier:

NCT04591522

Other Study ID Numbers:

Yongping_Chen

First Posted:

Oct 19, 2020

Last Update Posted:

Oct 19, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by First Affiliated Hospital of Wenzhou Medical University

Cirrhosis；fecal Microbiota Transplantation

Additional relevant MeSH terms:

Liver Cirrhosis

Fibrosis

Study Results

No Results Posted as of Oct 19, 2020