Small Intestinal Bacterial Overgrowth (SIBO) as pathogenetic mechanism of Functional Dyspepsia (FD)

• Conditions: Small Intestinal Bacterial Overgrowth; K30; Functional dyspepsia

• Registration Number: DRKS00011567
• Lead Sponsor: Hepatogastroenterology Unit, Second Department of Internal Medicine – Propaedeutic Research Institute and Diabetes Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-16
• Study Completion: 2018-12-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 483

Inclusion Criteria

Enrolled patients (Arm1) should have clinical evidence of Functional Dyspepsia.
Healthy controls (Arm 2) consist of participants that undergo upper gastrointestinal endoscopy in
terms of iron deficiency anaemia investigation and have no evidence of any liver disease. Arm 3 comprises of IBS (Irritable Bowel Syndrome) patients, which has been associated with SIBO (Small Intestinal Bacterial Overgrowth). Their epidemiological characteristics, duodenal fluid culture results, total bacterial count and peripheral blood samples are already available in our database.

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

For patients group (Arm 1):
1. No indications of other systematic diseases ie viral hepatitis, metabolic diseases or cancer

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare SIBO (Small Intestinal Bacterial Overgrowth) prevalence in patients between FD (Functional Dyspepsia), healthy controls and IBS (Irritable bowel Syndrome) patients using duodenal aspirate culture and qrt-PCR

Secondary Outcome Measures

Name	Time	Method
Investigate SIBO prevalence in the two FD patients subgroups (EPS, PDS)<br>Investigate SIBO prevalence in FD patients -and in patients subgroups (EPS, PDS)- compared to those suffering from Irritable bowel syndrome (IBS) and controls.<br>Determine the total bacterial count and M. Smithii count in FD patients and in the two FD subgroups (EPS, PDS).<br>Examine the relation of the severity of the dyspeptic symptoms as evaluated with the PAGI-SYM questionnaire with the presence of SIBO .<br>Examine a possible correlation between the quality of life of dyspeptic patients as evaluated with the PAGI-QoL questionnaire with the presence of SIBO.<br>Investigate potential association of SIBO in FD patients and gene polymorphisms implicated in its pathogenesis.<br>