Non-alcoholic fatty liver disease (NAFLD) - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

University Hospital Southampton NHS Foundation Trust.

Recruitment countries:

United Kingdom

Health condition studied:

Non-Alcoholic Fatty Liver Disease

URL:

Link to the clinical trial website

About the trial

Interventions:

Dietary Supplement: Maltodextrin
Dietary Supplement: Synbiotic

Key inclusion and exclusion criteria:

• 
  Inclusion Criteria:
  
  - Both men and women
  
  - Age > 18 years
  
  - Liver fat diagnosed on normal clinical grounds including in most cases liver assessed
  by Kleiner scoring system to classify severity, with no known aetiological factors
  for underlying liver disease (e.g. exclusion of hepatitis A, B & C, primary biliary
  cirrhosis, autoimmune hepatitis, haemochromatosis). Last liver biopsy will be within
  3 years of recruitment to the study.
  
  - Liver fat diagnosed by ultrasound, CT or magnetic resonance imaging (MRI) in patients
  who also have either diabetes and/or features of the metabolic syndrome, without
  evidence of known aetiological factors for underlying liver disease (e.g. exclusion
  of hepatitis A, B & C, primary biliary cirrhosis, autoimmune hepatitis,
  haemochromatosis).
  
  - Alcohol consumption = 14 units / week for women = 21 units / week for men.
  
  Exclusion Criteria:
  
  - Alcohol consumption > 15 units /week for women and > 22 units /week for men.
  
  - Decompensated acute or chronic liver disease.
  
  - A history of viral hepatitis, diarrhoea, diverticulosis, irritable bowel syndrome,
  inflammatory bowel diseases, coeliac disease (seropositivity for anti-endomysial
  immunoglobulin A antibodies; IgA EMA).
  
  - Previous bariatric or other abdominal surgery.
  
  - Continuous use of antibiotics that may change gut microflora, probiotics, or
  antisecretory drugs capable of causing achlorhydria within the 2 months preceding
  enrolment, or evidence of immunoglobulin A or immunoglobulin deficiency (both of
  which produce confounding effects during assessments of intestinal permeability and
  small intestinal bacterial overgrowth).
  

• Age minimum:  18 Years
• Age maximum:  N/A
• Gender:  Both

Primary outcomes:

Change in biomarkers for NAFLD and change in liver fat

Secondary outcomes:

Change in adipose tissue inflammation, satiety and risk factors for type 2 diabetes
Change in adipose tissue inflammation, satiety and risk factors for type 2 diabetes.

Target sample size:

100

Study type:

Interventional

Study design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Contacts:

• Name:   Christopher D Byrne, MBBCH PHD
• Address: 
• Phone:  44 23 8120 5006
• Email:  C.D.BYRNE@SOUTHAMPTON.AC.UK
• Affiliation: 

• Name:   Christopher D Byrne, MBBCh, PhD
• Address: 
• Phone: 
• Email: 
• Affiliation:  University of Southampton/University Hospital Southampton NHS Foundation Trust

• Name:   Christopher D Byrne, MBBCh, PhD
• Address: 
• Phone:  44 23 8120 5006
• Email:  C.D.BYRNE@SOUTHAMPTON.AC.UK
• Affiliation: 

Technical details

Scientific title:

Investigation of the Effects of a Synbiotic on Liver Fat, Disease Biomarkers and Intestinal Microbiota in Non-alcoholic Fatty Liver Disease

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

National Institute for Health Research, United Kingdom

Main ID:

NCT01680640

Secondary ID:

RHM MED1071

Register:

ClinicalTrials.gov

Date of registration:

24/08/2012

Date of first enrollment:

December 2013

Last refreshed:

24 October 2016