Skip to content

Pathophysiological analysis of small intestinal bacterial overgrowth (SIBO)

Pathophysiological analysis of small intestinal bacterial overgrowth (SIBO) - pathophysiology of small intestinal bacterial overgrowth (SIBO)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000057136
Enrollment
200
Registered
2025-02-26
Start date
2025-02-26
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Small intestinal bacterial overgrowth (SIBO)

Interventions

None listed

Sponsors

Tokai University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients suspected of having SIBO (1) Patients with abdominal symptoms such as abdominal distention and abdominal pain. (2) Patients with abnormal gas in the small intestine on plain abdominal X-ray or CT scan performed for medical reasons. (3) No evidence of organic disease (tumor, acute ulcerative lesion, severe stenosis or obstruction, etc.) on abdominal ultrasonography or upper gastrointestinal endoscopy performed for medical necessity. (4) No antimicrobial agents have been administered for 3 months prior to obtaining consent to participate in this study. (5) Age between 18 and 90 years old. (6) Consent for participation in this study is obtained from the patient by signing a consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of surgical operation for gastrointestinal diseases except for cholecystectomy, appendectomy, and hemorrhoidectomy. (2) Patients who have taken intestinal antiflatulents or intestinal peristaltic drugs within 1 month. (3) Those who have taken antibiotics within 3 months. (4) Diabetic patients with poor glycemic control (HbA1c >= 7.0%). (5) Patients taking alpha-glucosidase inhibitors. (6) Pregnant or possibly pregnant. (7) Patients with organic diseases (tumor, acute ulcerative lesion, severe stenosis or obstruction, etc.). (8) Other patients who are deemed inappropriate by the principal investigator and the study administrator.

Design outcomes

Primary

MeasureTime frame
Positive diagnostic rate of breath test as the gold standard for SIBO diagnosis by bacterial count. Sensitivity, specificity, positive predictive value, and negative predictive value of breath test.

Countries

Japan

Contacts

Public ContactTakayoshi Suzuki

Tokai University Hachioji Hospital Department of gastroenterology

takayosh@tokai.ac.jp042-639-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026