Fecal Microbiota Transplantation for Decompensated Cirrhosis

NCT ID: NCT03014505

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-07-31

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.

Conditions

Decompensated Cirrhosis; Fecal Microbiota Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FMT

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

Group Type: EXPERIMENTAL

FMT

Intervention Type: BIOLOGICAL

Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1

The traditional treatments

Group Type: ACTIVE_COMPARATOR

traditional treatments

Intervention Type: OTHER

traditional treatments for Decompensated Cirrhosis in part 2

Interventions

FMT

Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1

Intervention Type: BIOLOGICAL

traditional treatments

traditional treatments for Decompensated Cirrhosis in part 2

Intervention Type: OTHER

Other Intervention Names

Fecal Microbiota Transplantation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Chengdu Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiao-an Li, Ph.D

Role: STUDY_CHAIR

First Affiliated Hospital of Chengdu Medical College

Locations

IEC of Chengdu Medical College

Chendu, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Zhou, Ph.D

Role: CONTACT

zqlvzy319@163.com

+86-18981941992

Facility Contacts

Xiao-an Li, doctor

Role: primary

zqzy1983@163.com

+8613680868858

Other Identifiers

FMT-GYH

Identifier Type: -

Identifier Source: org_study_id