on Alcoholic Fatty Liver Disease (NAFLD) and Small Intestinal Bacterial Overgrowth (SIBO)
- Conditions
- Small Intestinal Bacterial OvergrowthK76.0K75.8K90.2Fatty (change of) liver, not elsewhere classifiedOther specified inflammatory liver diseasesBlind loop syndrome, not elsewhere classified
- Registration Number
- DRKS00009875
- Lead Sponsor
- Hepatogastroenterology Unit, Second Department of Internal Medicine and Research Institute, Attikon University General Hospital, Medical School, Athens University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Enrolled patients (Arm1) should have radiological and/or biochemical and/or histological evidence of fatty liver.
Healthy controls (Arm 2) consist of participants that undergo upper gastrointestinal endoscopy in terms of dyspepsia investigation and have no evidence of any liver disease.
Cirrhotic controls (Arm 3) consist of patients with cirrhosis of any etiology.
1. Age <18 years
2. Ongoing alcohol overconsumption
3. Recent use of antibiotics (within the last 3 months)
4. Recent upper gastrointestinal bleeding
5. Inability to provide informed consent
Additionally for the Patient Group:
1. Absence of any other liver related disease (viral hepatitis, metabolic liver diseases, hepatocellular carcinoma)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Compare SIBO prevelance in patients between NAFLD patients, healthy controls and cirrhotics using duodenal aspirate culture, breath test and qrt-PCR
- Secondary Outcome Measures
Name Time Method • Detecte a possible correlation between M. Smithii presence in small intestine and NAFLD/NASH using breath test and qrt-PCR.<br>• Determine the total bacterial count and M. Smithii count in feces with the use of qrt-PCR.<br>• Investigate a potential correlation of SIBO with the risk factors of NAFLD development.<br>• Determine the role of inflammatory process in NAFLD pathogenesis. <br>