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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1
traditional treatments for Decompensated Cirrhosis in part 2
IEC of Chengdu Medical College
Chendu, China
RECRUITINGNumber 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.
Time frame: 3 months
Improvement in liver function test as compared to baseline in both groups.
Time frame: 3 months
Reduction in systemic inflammatory markers like TNF-α in both groups.
Time frame: 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.
Time frame: 3 months
Reduction in systemic inflammatory markers like serum endotoxins in both groups.
Time frame: 3 months
Diamine oxidase(DAO)
Time frame: 3 months
Histological changes in the intestinal biopsy in both groups.
Time frame: 3 months
Microbiota composition
Deep sequencing of the microbiota at baseline and post-FMT.
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.