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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03803540
Other study ID # FMT-NASH
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date May 1, 2022
Est. completion date April 1, 2023

Study information

Verified date April 2022
Source Puerta de Hierro University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date April 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Fecal Microbiota Transplantation
Fecal Microbiota Transplantation via duodenal infusion

Locations

Country Name City State
Spain Puerta de Hierro University Hospital Majadahonda Madrid

Sponsors (2)

Lead Sponsor Collaborator
Puerta de Hierro University Hospital Hospital Universitario Marqués de Valdecilla

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy (Histological resolution of NASH defined as ballooning disappearance with or without persistence of minimal lobulillar inflammation and no progression of fibrosis stage) 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. 72 weeks
Secondary Safety (Appearance of adverse events related with Fecal Microbiota Transplantation) Appearance of adverse events related with Fecal Microbiota Transplantation will be recorded during 72 weeks follow-up. 72 weeks
Secondary Microbiota composition (Changes in microbiota diversity profile related with Fecal Microbiota Transplantation via 16S rRNA analysis) Changes in microbiota diversity profile related with Fecal Microbiota Transplantation procedure. 16S rRNA sequencing techniques will be applied on stool samples. 72 weeks
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