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Fecal Microbiota Transplantation for the Treatment of Non-Alcoholic Steatohepatitis (FMT-NASH)

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ClinicalTrials.gov Identifier: NCT03803540
Recruitment Status : Not yet recruiting
First Posted : January 14, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
Hospital Universitario Marqués de Valdecilla
Information provided by (Responsible Party):
Jose Luis Calleja, Puerta de Hierro University Hospital

Brief Summary:

Human microbiota is the set of microorganisms that, in a symbiotic way, coexist and develop in the different surfaces (skin and mucous membranes) of the human body. It is estimated that it is composed of approximately 10^14 bacteria and other unicellular life forms . The gastrointestinal (GI) tract is the organ in which the microbiota reaches its greatest complexity, influencing its metabolic activities in different organs and human systems.

Human microbiota plays a role in multiple homeostatic and physiological functions including energy and intermediary metabolism, normal immune responses, and even appropriate bowel development and nervous system functioning. Given its vascular supply, the liver plays important roles in metabolism and immunological functions. It receives 70% of blood supply through the portal vein which carries all metabolic products derived from GI microbiota.

Non alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in developed countries (with an estimated prevalence around 25 - 40% of adults) and it is expected that the burden of disease will increase in the near future. This condition can progress through a spectrum of progressive liver damage to non alcoholic steatohepatitis (NASH), liver fibrosis, cirrhosis and liver cancer. Around 20-30% of NAFLD patients develop NASH, with a lower rate progressing further to fibrosis and cirrhosis. Currently, there is no approved pharmacological or interventional treatment for the management of this so prevalent disease, apart from changes in lifestyle aiming weight loss.

The aim of the present pilot study is to assess the efficacy and safety of microbiota manipulation by means of Fecal Microbiota Transplantation in the treatment of patients with NASH.


Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Non Alcoholic Steatohepatitis Other: Fecal Microbiota Transplantation Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation for the Treatment of Non-Alcoholic Steatohepatitis, a Pilot Study.
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : April 1, 2021


Arm Intervention/treatment
Experimental: Fecal Microbiota Transplantation
Lean healthy donor frozen fecal microbiota will be administered via duodenal infusion in an upper gastrointestinal endoscopy
Other: Fecal Microbiota Transplantation
Fecal Microbiota Transplantation via duodenal infusion




Primary Outcome Measures :
  1. Efficacy (Histological resolution of NASH defined as ballooning disappearance with or without persistence of minimal lobulillar inflammation and no progression of fibrosis stage) [ Time Frame: 72 weeks ]
    Two liver biopsy samples (one pre-FMT and the second 72 weeks after FMT) will be taken. Resolution of NASH is defined as ballooning disappearance with or without persistence of minimal lobulillar inflammation and no progression of fibrosis stage. NAFLD Activity Score is the histological scale that will be used.


Secondary Outcome Measures :
  1. Safety (Appearance of adverse events related with Fecal Microbiota Transplantation) [ Time Frame: 72 weeks ]
    Appearance of adverse events related with Fecal Microbiota Transplantation will be recorded during 72 weeks follow-up.

  2. Microbiota composition (Changes in microbiota diversity profile related with Fecal Microbiota Transplantation via 16S rRNA analysis) [ Time Frame: 72 weeks ]
    Changes in microbiota diversity profile related with Fecal Microbiota Transplantation procedure. 16S rRNA sequencing techniques will be applied on stool samples.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Mass Index > 30 Kg / m^2
  • Histological evidence of NASH (by means of hepatic percutaneous biopsy obtained in the previous six months) defined as at least 1 point in each category of NAFLD Activity Score with a fibrosis stage between 0 and 3.
  • Global NAFLD Activity Score >= 4 points
  • For patients with fibrosis stage 0 or 1, NAFLD Activity Score should be >= 5 points and they should have one of the following comorbidities: Metabolic Syndrome, type 2 diabetes mellitus or Homeostasis Model Assessment - Insulin Resistance (HOMA-IR) > 6.

Exclusion Criteria:

  • Patients unable or unwilling to give the informed consent
  • Patients actively participating in another clinical trial or investigational protocol
  • Cirrhosis of the liver: Transient elastography > 20 kilopascal or histological evidence of it (grade 4 fibrosis)
  • Alcoholic consumption greater than 14 g / week in women or 21 g / week in men
  • Any significant hepatic comorbidity: chronic active viral hepatitis, cholestatic disease, hemochromatosis or Wilson disease
  • HIV infection
  • Liver transplantation
  • Hepatocellular carcinoma
  • Women during pregnancy or breastfeeding
  • Portal thrombosis
  • Non-cirrhotic portal hypertension
  • Gastroesophageal varices
  • Previous gastrointestinal tract major surgery (excluding appendectomy and cholecystectomy)
  • Previous Fecal Microbiota Transplantation
  • Chronic significant kidney or heart disease
  • Life expectancy lower than two years
  • Chronic use of steatogenic drugs
  • Chronic use of immunosuppressants

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): NCT03803540


Locations
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Spain
Puerta de Hierro University Hospital Active, not recruiting
Majadahonda, Madrid, Spain, 28222
Sponsors and Collaborators
Puerta de Hierro University Hospital
Hospital Universitario Marqués de Valdecilla

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Responsible Party: Jose Luis Calleja, Head of the department of Gastroenterology and Hepatology, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT03803540     History of Changes
Other Study ID Numbers: FMT-NASH
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Jose Luis Calleja, Puerta de Hierro University Hospital:
Non-Alcoholic Fatty Liver Disease
Non Alcoholic Steatohepatitis
NAFLD
NASH
Fecal Microbiota Transplantation
FMT

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases