Fecal Microbiota Transplantation for Decompensated Cirrhosis

Phase 1

• Conditions: Fecal Microbiota Transplantation; Decompensated Cirrhosis
• Interventions: Biological: FMT; Other: traditional treatments

• Registration Number: NCT03014505
• Lead Sponsor: First Affiliated Hospital of Chengdu Medical College

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.

Study Timeline

• Study Start: 2016-08
• Status Verified: 2017-01
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-06
• Last Update Submitted: 2017-01-06
• Study First Posted: 2017-01-09
• Last Update Posted: 2017-01-09
• Primary Completion: 2018-03
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMT	FMT	Fecal Microbiota Transplantation via endoscope and/or cenema and the traditional treatments
The traditional treatments	traditional treatments	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events complication rate in all patients in both groups	3 months	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

Name	Time	Method
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.	3 months	Improvement is defined as improvement in Intestinal mucosa structure pre and post treatment.
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	3 months	Deep sequencing of the microbiota at baseline and post-FMT.

Trial Locations

Locations (1)

IEC of Chengdu Medical College; 🇨🇳 Chendu, China