Clinical trial NCT03014505: Fecal Microbiota Transplantation for Decompensated Cirrhosis
Official title: Fecal Microbiota Transplantation Versus Standard Therapy in Decompensated Cirrhosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Decompensated Cirrhosis
Fecal Microbiota Transplantation
Keywords: Cirrhosis
Fecal Microbiota Transplantation
Intestinal flora
Intestinal mucosal barrier
Intestinal Bacteria Flora Disturbance
Lead sponsor: First Affiliated Hospital of Chengdu Medical College
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of adverse events complication rate in all patients in both groups
timeFrame: 3 months
Secondary outcomes:
measure: Improvement in liver function test as compared to baseline in both groups.
timeFrame: 3 months
measure: Reduction in systemic inflammatory markers like TNF-α in both groups.
timeFrame: 3 months
measure: Reduction in systemic inflammatory markers like IL-6 in both groups.
timeFrame: 3 months
measure: Reduction in systemic inflammatory markers like serum endotoxins in both groups.
timeFrame: 3 months
measure: Diamine oxidase（DAO）
timeFrame: 3 months
measure: Histological changes in the intestinal biopsy in both groups.
timeFrame: 3 months
measure: Microbiota composition
timeFrame: 3 months
Other outcomes:
Locations:
city: Chendu
country: China
facility: IEC of Chengdu Medical College
Study officials:
affiliation: First Affiliated Hospital of Chengdu Medical College
name: Xiao-an Li, Ph.D
role: STUDY_CHAIR
References: