Status:
UNKNOWN
Fecal Microbiota Transplantation for the Treatment of Non-Alcoholic Steatohepatitis
Lead Sponsor:
Puerta de Hierro University Hospital
Collaborating Sponsors:
Hospital Universitario Marqués de Valdecilla
Conditions:
Non-Alcoholic Fatty Liver Disease
Non Alcoholic Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03803540
Start Date
May 1 2022
End Date
April 1 2023
Last Update
April 14 2022
Active Locations (1)
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1
Puerta de Hierro University Hospital
Majadahonda, Madrid, Spain, 28222