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Fecal Microbiota Transplantation in Cirrhosis (FMT)

Primary Purpose

Cirrhosis, Liver

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Healthy fecal bacteria liquid

About this trial

This is an interventional treatment trial for Cirrhosis, Liver focused on measuring Cirrhosis；fecal Microbiota Transplantation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FMT group

control group

Arm Description

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.

Outcomes

Primary Outcome Measures

blood ammonia

blood ammonia in umol/L

alanine aminotransferase

alanine aminotransferase in U/L

aspartate aminotransferase

aspartate aminotransferase in U/L

gut microbiome

16S RNA sequencing in gut microbiome

white blood cell

white blood cell in /L

hemoglobin

hemoglobin in g/L

blood platelet

blood platelet in/L

albumin

albumin in g/L

blood glucose

blood glucose in mmol/L

Serum creatinine

Serum creatinine in umol/L

direct bilirubin

direct bilirubin in umol/L

indirect bilirubin

indirect bilirubin in umol/L

prothrombin time activity percentage

prothrombin time activity percentage in %

liver stiffness

liver stiffness in Kpa

Secondary Outcome Measures

Concentration of HIF-1α in intestine

Concentration of HIF-1α expression in intestine by western blot

Full Information

NCT ID

NCT04591522

First Posted

August 25, 2020

Last Updated

October 11, 2020

Sponsor

First Affiliated Hospital of Wenzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04591522

Brief Title

Fecal Microbiota Transplantation in Cirrhosis

Acronym

FMT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 15, 2020 (Anticipated)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis, Liver

Keywords

Cirrhosis；fecal Microbiota Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FMT group

Arm Type

Experimental

Arm Description

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.

Arm Title

control group

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Healthy fecal bacteria liquid

Intervention Description

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

Primary Outcome Measure Information:

Title

blood ammonia

Description

blood ammonia in umol/L

Time Frame

Change from baseline blood ammonia at 12 months

Title

alanine aminotransferase

Description

alanine aminotransferase in U/L

Time Frame

Change from baseline alanine aminotransferase at 12 months

Title

aspartate aminotransferase

Description

aspartate aminotransferase in U/L

Time Frame

Change from baseline aspartate aminotransferase at 12 months

Title

gut microbiome

Description

16S RNA sequencing in gut microbiome

Time Frame

Change from baseline gut microbiome at 12 months

Title

white blood cell

Description

white blood cell in /L

Time Frame

Change from baseline white blood cell at 12 months

Title

hemoglobin

Description

hemoglobin in g/L

Time Frame

Change from baseline hemoglobin at 12 months

Title

blood platelet

Description

blood platelet in/L

Time Frame

Change from baseline blood platelet at 12 months

Title

albumin

Description

albumin in g/L

Time Frame

Change from baseline albumin at 12 months

Title

blood glucose

Description

blood glucose in mmol/L

Time Frame

Change from baseline blood glucose at 12 months

Title

Serum creatinine

Description

Serum creatinine in umol/L

Time Frame

Change from baseline serum creatinine at 12 months

Title

direct bilirubin

Description

direct bilirubin in umol/L

Time Frame

Change from baseline direct bilirubin at 12 months

Title

indirect bilirubin

Description

indirect bilirubin in umol/L

Time Frame

Change from baseline indirect bilirubin at 12 months

Title

prothrombin time activity percentage

Description

prothrombin time activity percentage in %

Time Frame

Change from baseline prothrombin time activity percentage at 12 months

Title

liver stiffness

Description

liver stiffness in Kpa

Time Frame

Change from baseline liver stiffness at 12 months

Secondary Outcome Measure Information:

Title

Concentration of HIF-1α in intestine

Description

Concentration of HIF-1α expression in intestine by western blot

Time Frame

Change from baseline HIF-1α expression in intestine at 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yongping Chen, Prof

Phone

+8613505777281

did@wzhospital.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

yongping Chen, Prof

Organizational Affiliation

First Affiliated Hospital of Wenzhou Medical University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31004827

Citation

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.

Results Reference

result

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Fecal Microbiota Transplantation in Cirrhosis

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