A Study of Breath Testing for Small Intestinal Bacterial Overgrowth

Not Applicable

Recruiting

• Conditions: Regurgitation; Gastroesophageal Reflux; Heartburn
• Interventions: Other: Breath Testing

• Registration Number: NCT05976165
• Lead Sponsor: Mayo Clinic

Brief Summary

Researchers hope to determine how often small intestinal bacterial overgrowth occurs after taking proton pump inhibitors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-07-27
• Study First Posted: 2023-08-04
• Study Start: 2023-11-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breath Test Evaluation for SIBO	Breath Testing	Subjects with symptoms of gastroesophageal reflux disease (GERD) treated with a short course of proton pump inhibitors (PPI) clinically will undergo breath testing evaluating for small intestinal bacterial overgrowth (SIBO).

Primary Outcome Measures

Name	Time	Method
Incidence of SIBO after treatment with PPI	After PPI therapy, approximately 8 weeks	Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) after clinical treatment of proton pump inhibitors (PPI ).

Secondary Outcome Measures

Name	Time	Method
Symptoms of SIBO after treatment with PPI	After PPI therapy, approximately 8 weeks	Measured using the self-reported Mayo Bloating Questionnaire to assess symptoms of bloating and abdominal distension. Comprised of 45 questions addressing symptoms of bloating/distention. Other questionnaires include a diarrhea survey and the GERDQ.
Symptoms of SIBO before treatment with a PPI	Baseline	Measured using the self-reported Mayo Bloating Questionnaire to assess symptoms of bloating and abdominal distension. Comprised of 45 questions addressing symptoms of bloating/distention. Other questionnaires include a diarrhea survey and the GERDQ.
Incidence of SIBO before treatment with a PPI	Baseline	Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) before clinical treatment of proton pump inhibitors (PPI ).

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States