Non Alcoholic Fatty Liver Disease (NAFLD) and Small Intestinal Bacterial Overgrowth (SIBO)

Non Alcoholic Fatty Liver Disease (NAFLD) and Small Intestinal Bacterial Overgrowth (SIBO) - NAFLD and SIBO

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00009875

Enrollment

Registered

2016-02-16

Start date

2015-03-31

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Intestinal Bacterial Overgrowth K76.0 K75.8 K90.2

Interventions

Group 1: Subjects who have radiological and/or biochemical and/or histological evidence of fatty liver. Diagnostic Tests: Initial visit: Patient’s history, physical examination, baseline labor exam

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
• Compare SIBO prevelance in patients between NAFLD patients, healthy controls and cirrhotics using duodenal aspirate culture, breath test and qrt-PCR	—

Secondary

Measure	Time frame
• Detecte a possible correlation between M. Smithii presence in small intestine and NAFLD/NASH using breath test and qrt-PCR. • Determine the total bacterial count and M. Smithii count in feces with the use of qrt-PCR. • Investigate a potential correlation of SIBO with the risk factors of NAFLD development. • Determine the role of inflammatory process in NAFLD pathogenesis.	—

Countries

Greece

Contacts

Public ContactParaskevas Gkolfakis

Hepatogastroenterology Unit, Second Department of Internal Medicine and Research Institute, Attikon University General Hospital, Medical School, Athens University

pgkolfakis@med.uoa.gr00306974454742

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026