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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
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:
The study will be conducted in the Department of Hepatology, Institute of Liver & Biliary Sciences, New Delhi. As a part of this study history will be taken and clinical examination will be done. Subjects will be screened for diagnosis of NASH (Non Alcoholic Steatohepatitis) cirrhosis. If subjects are found to have NASH (Non Alcoholic Steatohepatitis) cirrhosis, they will be chosen to receive stool from healthy donor, which is voluntarily donated by a healthy donor related or unrelated to the subjects and the stool will be prepared using standard guidelines. The prepared sample of stool, about 50 ml will be instilled into proximal small intestine by way of a thin and soft tube inserted through nose. This administration of sample, 50 ml daily will occur once a month every month for 6 months. The liver function parameters will be assessed and thereafter at 1 month and 3 months & subjects will be clinically assessed for improvement or worsening.

Condition or disease Intervention/treatment Phase
NASH Related Decompensated Cirrhosis Drug: Fecal Microbiota Transplantation Drug: Standard Treatment Other: Weight Reduction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Standard Treatment

Other: Weight Reduction
routine exercise for weight reduction




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Reduction in HVPG (Hepatic Venous Pressure Gradient) in the two groups from baseline at 12 month [ Time Frame: 1 year ]
  2. Improvement in liver function test as compared to baseline in both groups. [ Time Frame: 1 year ]
  3. Improvement in HVPG (Hepatic Venous Pressure Gradient) as compared to baseline in both groups. [ Time Frame: 1 year ]
  4. 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.

  5. Improvement in liver stiffness as measured by fibroscan test as compared to baseline in both groups. [ Time Frame: 1 year ]
  6. 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

  7. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age more than 18 years.
  2. All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
  3. Histological evidence of definite or probable NASH (Non Alcoholic Steatohepatitis) based upon a liver biopsy prior to enrollment and a NAFLD (Non Alcoholic Fatty Liver Disease) activity score (NAS) ≥5 with ≥1 in each component of the NAS score (steatosis, scored 0-3, ballooning degeneration, 0-2, and lobular inflammation, 0-3).
  4. No history of recent spontaneous bacterial peritonitis.(1 month)
  5. Child Pugh Score of 6 - 10

Exclusion Criteria:

  1. Diagnosis of liver disease other than NASH (Non Alcoholic Steatohepatitis) cirrhosis
  2. Ongoing bacterial infection requiring antibiotic treatment.
  3. Current or history of significant alcohol consumption for a period of more than 3
  4. consecutive months within 1 year prior to screening
  5. Treatment with antibiotics or probiotics in the preceding 3 months.
  6. Inability to safely obtain a liver biopsy in compensated cirrhosis or to perform an upper GastroIntestinal endoscopy
  7. Pregnant patients

Information from the National Library of Medicine

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


Contacts
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Contact: Dr Kapil Dev Jamwal, DM 011-46300000 drkapil222@gmail.com

Locations
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India
Institute of Liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
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Principal Investigator: Dr Kapil Dev Jamwal, DM Institute of Liver and Biliary Sciences

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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT02868164     History of Changes
Other Study ID Numbers: ILBS-Cirrhosis-05
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases