Clinical Trials Logo
  1. Home
  2. Non-Alcoholic Steatohepatitis
  3. NCT03803540

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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:
Fecal Microbiota Transplantation for the Treatment of Non-Alcoholic Steatohepatitis, a Pilot Study.

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03803540
Study type Interventional
Source Puerta de Hierro University Hospital
Contact
Status Not yet recruiting
Phase Phase 1
Start date May 1, 2022
Completion date April 1, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05480696 - Soluble Fibre Supplementation in NAFLD Phase 1
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Completed NCT04671186 - Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan N/A
Recruiting NCT05979779 - Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis Phase 2
Recruiting NCT05462353 - Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH Phase 2
Completed NCT05006885 - ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD) Phase 1
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Recruiting NCT04365855 - The Olmsted NAFLD Epidemiology Study (TONES) N/A
Recruiting NCT05618626 - Prevention of NAFLD and CVD Through Lifestyle Intervention N/A
Completed NCT03256526 - 6-week Safety and PD Study in Adults With NAFLD Phase 2
Enrolling by invitation NCT06152991 - Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy Phase 3
Completed NCT03681457 - Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects Phase 1
Completed NCT06244550 - Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors N/A
Not yet recruiting NCT05120557 - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH N/A
Completed NCT03060694 - Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements
Completed NCT02526732 - Hepatic Inflammation and Physical Performance in Patients With NASH N/A
Recruiting NCT01988441 - The Influence of Autophagy on Fatty Liver
Recruiting NCT01680003 - Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease Phase 2
Completed NCT01712711 - Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease Phase 2
Recruiting NCT00941642 - Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease Phase 4