Fecal Microbiota Transplantation for Decompensated Cirrhosis (FMTDC)

Fecal Microbiota Transplantation Versus Standard Therapy in Decompensated Cirrhosis: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Decompensated Cirrhosis; Fecal Microbiota Transplantation
• Intervention / Treatment: Biological: FMT; Other: traditional treatments

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yan Zhou, Ph.D; Phone Number: +86-18981941992; Email: zqlvzy319@163.com

Study Locations

• China
  • Chendu, China, 610500
    • Recruiting
    • IEC of Chengdu Medical College
    • Contact: Xiao-an Li, doctor; Phone Number: +8613680868858; Email: zqzy1983@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMT; Fecal Microbiota Transplantation via endoscope and/or cenema and the traditional treatments	Biological: FMT; Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1; Other Names: Fecal Microbiota Transplantation
Active Comparator: The traditional treatments	Other: traditional treatments; traditional treatments for Decompensated Cirrhosis in part 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in liver function test as compared to baseline in both groups.		3 months
Reduction in systemic inflammatory markers like TNF-α in both groups.		3 months
Reduction in systemic inflammatory markers like IL-6 in both groups.	Improvement is defined as improvement in Intestinal mucosa structure pre and post treatment.	3 months
Reduction in systemic inflammatory markers like serum endotoxins in both groups.		3 months
Diamine oxidase（DAO）		3 months
Histological changes in the intestinal biopsy in both groups.		3 months
Microbiota composition	Deep sequencing of the microbiota at baseline and post-FMT.	3 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chengdu Medical College
• Investigators: Study Chair: Xiao-an Li, Ph.D, First Affiliated Hospital of Chengdu Medical College

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (Estimate): January 9, 2017

Study Record Updates

• Last Update Posted (Estimate): January 9, 2017
• Last Update Submitted That Met QC Criteria: January 6, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Fecal Microbiota Transplantation; Cirrhosis; Intestinal flora; Intestinal mucosal barrier; Intestinal Bacteria Flora Disturbance
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: FMT-GYH

Plan for Individual participant data (IPD)

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