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Fecal Microbiota Transplantation for Decompensated Cirrhosis (FMTDC)

Primary Purpose

Decompensated Cirrhosis, Fecal Microbiota Transplantation

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
FMT
traditional treatments
Sponsored by
First Affiliated Hospital of Chengdu Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decompensated Cirrhosis focused on measuring Cirrhosis, Fecal Microbiota Transplantation, Intestinal flora, Intestinal mucosal barrier, Intestinal Bacteria Flora Disturbance

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. >18 years of age
  2. Agreed to participate in this clinical study and signed informed consent, follow-up time greater than 3 months.
  3. Comply with the diagnostic criteria of decompensated liver cirrhosis, including liver function damage, portal hypertension clinical manifestations, laboratory and imaging studies.

Exclusion Criteria:

  1. Ongoing bacterial infection requiring antibiotic treatment.
  2. current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average).
  3. consecutive months within 1 year prior to screening.
  4. Treatment with antibiotics or probiotics in the preceding 3 months.
  5. Inability to safely perform an GastroIntestinal endoscopy.
  6. No history of recent spontaneous bacterial peritonitis or gastrointestinal bleeding.(14 days).
  7. Human Immunodeficiency Virus (HIV) infection.
  8. Active, serious medical disease with likely life expectancy less than 5 years.
  9. Active substance abuse including inhaled or injection drugs in the year prior to screening.
  10. pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial, breast feeding.
  11. Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study.
  12. History of severe (anaphylactic) food allergy.
  13. History of gastroparesis or altered gastric motility -
  14. Psychiatric disorder

Sites / Locations

  • IEC of Chengdu Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FMT

The traditional treatments

Arm Description

Fecal Microbiota Transplantation via endoscope and/or cenema and the traditional treatments

Outcomes

Primary Outcome Measures

Number of adverse events complication rate in all patients in both groups
Adverse events like the general situation, defecate situation and possible clinical events, including: Incidence of new onset upper gastrointestinal bleed in both groups; development of new onset of ascites in both groups.; Number of Spontaneous Bacterial peritonitis cases in both groups. Acute on Chronic Liver failure cases in both groups.

Secondary Outcome Measures

Improvement in liver function test as compared to baseline in both groups.
Reduction in systemic inflammatory markers like TNF-α in both groups.
Reduction in systemic inflammatory markers like IL-6 in both groups.
Improvement is defined as improvement in Intestinal mucosa structure pre and post treatment.
Reduction in systemic inflammatory markers like serum endotoxins in both groups.
Diamine oxidase(DAO)
Histological changes in the intestinal biopsy in both groups.
Microbiota composition
Deep sequencing of the microbiota at baseline and post-FMT.

Full Information

First Posted
January 3, 2017
Last Updated
January 6, 2017
Sponsor
First Affiliated Hospital of Chengdu Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT03014505
Brief Title
Fecal Microbiota Transplantation for Decompensated Cirrhosis
Acronym
FMTDC
Official Title
Fecal Microbiota Transplantation Versus Standard Therapy in Decompensated Cirrhosis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Chengdu Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Imbalance of gut bacteria is suspected to play a key role driving the progression of cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study will determine if fecal microbiota transplantation is an effective and safe treatment for decompensated cirrhosis.
Detailed Description
Two groups of inpatients with decompensated cirrhosis will be randomized using random sequence generator into experimental and control groups. Two groups will given traditional treatments and experimental group will added treatment with fecal microbiota transplantation via endoscope and/or cenema.The liver function parameters, adverse events complication, systemic inflammatory markers, Intestinal mucosa structure, permeability changes in the intestinal mucosal barrier, Microbiota composition will be assessed and thereafter at 1 month and 3 months & subjects will be clinically assessed for improvement or worsening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Cirrhosis, Fecal Microbiota Transplantation
Keywords
Cirrhosis, Fecal Microbiota Transplantation, Intestinal flora, Intestinal mucosal barrier, Intestinal Bacteria Flora Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FMT
Arm Type
Experimental
Arm Description
Fecal Microbiota Transplantation via endoscope and/or cenema and the traditional treatments
Arm Title
The traditional treatments
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
FMT
Other Intervention Name(s)
Fecal Microbiota Transplantation
Intervention Description
Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1
Intervention Type
Other
Intervention Name(s)
traditional treatments
Intervention Description
traditional treatments for Decompensated Cirrhosis in part 2
Primary Outcome Measure Information:
Title
Number of adverse events complication rate in all patients in both groups
Description
Adverse events like the general situation, defecate situation and possible clinical events, including: Incidence of new onset upper gastrointestinal bleed in both groups; development of new onset of ascites in both groups.; Number of Spontaneous Bacterial peritonitis cases in both groups. Acute on Chronic Liver failure cases in both groups.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improvement in liver function test as compared to baseline in both groups.
Time Frame
3 months
Title
Reduction in systemic inflammatory markers like TNF-α in both groups.
Time Frame
3 months
Title
Reduction in systemic inflammatory markers like IL-6 in both groups.
Description
Improvement is defined as improvement in Intestinal mucosa structure pre and post treatment.
Time Frame
3 months
Title
Reduction in systemic inflammatory markers like serum endotoxins in both groups.
Time Frame
3 months
Title
Diamine oxidase(DAO)
Time Frame
3 months
Title
Histological changes in the intestinal biopsy in both groups.
Time Frame
3 months
Title
Microbiota composition
Description
Deep sequencing of the microbiota at baseline and post-FMT.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18 years of age Agreed to participate in this clinical study and signed informed consent, follow-up time greater than 3 months. Comply with the diagnostic criteria of decompensated liver cirrhosis, including liver function damage, portal hypertension clinical manifestations, laboratory and imaging studies. Exclusion Criteria: Ongoing bacterial infection requiring antibiotic treatment. current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average). consecutive months within 1 year prior to screening. Treatment with antibiotics or probiotics in the preceding 3 months. Inability to safely perform an GastroIntestinal endoscopy. No history of recent spontaneous bacterial peritonitis or gastrointestinal bleeding.(14 days). Human Immunodeficiency Virus (HIV) infection. Active, serious medical disease with likely life expectancy less than 5 years. Active substance abuse including inhaled or injection drugs in the year prior to screening. pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial, breast feeding. Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study. History of severe (anaphylactic) food allergy. History of gastroparesis or altered gastric motility - Psychiatric disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhou, Ph.D
Phone
+86-18981941992
Email
zqlvzy319@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-an Li, Ph.D
Organizational Affiliation
First Affiliated Hospital of Chengdu Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
IEC of Chengdu Medical College
City
Chendu
ZIP/Postal Code
610500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao-an Li, doctor
Phone
+8613680868858
Email
zqzy1983@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Fecal Microbiota Transplantation for Decompensated Cirrhosis

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