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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011567

Enrollment

228

Registered

2017-03-16

Start date

2016-04-05

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 K30

Interventions

Group 1: Arm 1: Subjects who fullfill criteria for Functional Dyspepsia. Diagnostic Tests: Initial visit: Patient’s history, physical examination, baseline labor examinations and recent and ongoing

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Countries

Greece

Contacts

Public ContactGeorgios Tziatzios

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

gtziatzios@med.uoa.gr0030 210 5832089

Outcome results

None listed

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