Fecal Microbiota Transplantation for Decompensated Cirrhosis (FMTDC)

First Affiliated Hospital of Chengdu Medical College

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Decompensated Cirrhosis; Fecal Microbiota Transplantation

Treatments: Biological: FMT; Other: traditional treatments

Study type: Interventional

Funder types: Other

Identifiers

NCT03014505

FMT-GYH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

FMT

Experimental group

Description:

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

Treatment:

Biological: FMT

The traditional treatments

Active Comparator group

Treatment:

Other: traditional treatments