Fecal Microbiota Therapy Versus Standard Therapy in Decompensated NASH Related Cirrhosis: A Randomized Controlled Trial.
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|ClinicalTrials.gov Identifier: NCT02868164|
Recruitment Status : Not yet recruiting
First Posted : August 16, 2016
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|NASH Related Decompensated Cirrhosis||Drug: Fecal Microbiota Transplantation Drug: Standard Treatment Other: Weight Reduction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Therapy Versus Standard Therapy in Decompensated NASH Related Cirrhosis: A Randomized Controlled Trial.|
|Estimated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
|Experimental: Fecal Microbiota Transplantation (FMT)||
Drug: Fecal Microbiota Transplantation
The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 6 month.
|Active Comparator: Weight Reduction||
Drug: Standard Treatment
Other: Weight Reduction
routine exercise for weight reduction
- Number of adverse events complication rate in NASH (Non Alcoholic Steatohepatitis) patients in both groups [ Time Frame: 1 year ]Adverse events like GastroIntestinal Bleed, development of ascites, Spontaneous Bacterial peritonitis, ACLF (acute on chronic liver failure)
- Reduction in HVPG (Hepatic Venous Pressure Gradient) in the two groups from baseline at 12 month [ Time Frame: 1 year ]
- Improvement in liver function test as compared to baseline in both groups. [ Time Frame: 1 year ]
- Improvement in HVPG (Hepatic Venous Pressure Gradient) as compared to baseline in both groups. [ Time Frame: 1 year ]
- Improvement duodenal biopsy as compared to baseline in both groups. [ Time Frame: 1 year ]Improvement is defined as improvement in microbiome pre and post treatment.
- Improvement in liver stiffness as measured by fibroscan test as compared to baseline in both groups. [ Time Frame: 1 year ]
- Improvement in insulin resistance in both groups. [ Time Frame: 1 year ]Improvement is defined as improvement in the fasting plasma and insulin levels, HOMA-IR
- Reduction in hepatic and systemic inflammatory markers in both groups [ Time Frame: 1 year ]Hepatic and systemic inflammatory like Tumor Necrosis Factor-α, CRP and serum endotoxins.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868164
|Contact: Dr Kapil Dev Jamwal, DMfirstname.lastname@example.org|
|Institute of Liver and Biliary Sciences||Recruiting|
|New Delhi, Delhi, India, 110070|
|Principal Investigator:||Dr Kapil Dev Jamwal, DM||Institute of Liver and Biliary Sciences|