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

Recruitment status:

Recruiting

Primary Sponsor:

University of Edinburgh

Recruitment countries:

United Kingdom

Health condition studied:

Non-alcoholic Fatty Liver Disease

URL:

Link to the clinical trial website

About the trial

Interventions:

Device: Breath analysis - electronic signature "Breath-print"

Key inclusion and exclusion criteria:

• 
  Inclusion Criteria:
  
  - Healthy individuals with no known or self declared medical illness with BMI (body
  mass index) within normal range (18.5-25)
  
  - Non alcoholic fatty liver disease without cirrhosis
  
  - Compensated (no evidence of ascites, encephalopathy) NAFLD cirrhosis; assessed by
  scoring system - Child's Pugh
  
  Exclusion Criteria:
  
  - Ongoing or recent (within last 6months) alcohol consumption more than 21 units per
  week for males and 14 units per week for females.
  
  - BMI > 40
  
  - Chronic respiratory disease e.g. Chronic obstructive pulmonary disease (COPD),
  asthma, interstitial fibrosis
  
  - Use of antibiotics within last 4 weeks of sample collection and inflammatory bowel
  disease, irritable bowel syndrome, celiac sprue, or other chronic inflammatory
  diseases of the intestines (for intestinal microbiome analysis)
  
  - Other known liver disease e.g. Primary Biliary Cholangitis/cirrhosis (PBC), Alcoholic
  liver disease (ALD), Autoimmune and hepatitis
  
  - Inability to provide informed consent.
  
  - Participation in other clinical intervention/drug trial
  

• Age minimum:  18 Years
• Age maximum:  75 Years
• Gender:  Both

Primary outcomes:

Characterisation of exhaled breath composition
Characterise the electronic signature "breath-print" in pre-defined cohorts

Secondary outcomes:

Profiling intestinal microbiome and assessing end-metabolic products in urine

Target sample size:

90

Study type:

Observational

Study design:

Observational Model: Cohort, Time Perspective: Prospective

Contacts:

• Name:   Peter C Hayes, MD,PhD,FRCPE
• Address: 
• Phone: 
• Email: 
• Affiliation:  Centre for liver and digestive disorder, Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA

• Name:   Rohit Sinha, MRCP,PgDip
• Address: 
• Phone:  +44 131 2421625
• Email:  rohit.sinha@nhs.net
• Affiliation: 

• Name:   Rohit Sinha, MRCP,PgDip
• Address: 
• Phone:  +44 131 2421625
• Email:  rohit.sinha@nhs.net
• Affiliation: 

Technical details

Scientific title:

Breath Analysis Using an Electronic Nose in Non Alcoholic Fatty Liver Disease (BEN) Study

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

University of Strathclyde
VU University of Amsterdam

Main ID:

NCT02950610

Secondary ID:

165914

Register:

ClinicalTrials.gov

Date of registration:

13/01/2016

Date of first enrollment:

January 2016

Last refreshed:

7 November 2016