A Study of Breath Testing for Small Intestinal Bacterial Overgrowth

NCT05976165 | Recruiting

• 1 other identifier: 22-007268
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroesophageal Reflux; Regurgitation; Heartburn

Keywords

Proton pump inhibitor

Outcome Measures

Primary Outcomes (1)

• Incidence of SIBO after treatment with PPI

  Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) after clinical treatment of proton pump inhibitors (PPI ).

  After PPI therapy, approximately 8 weeks

Secondary Outcomes (3)

• Symptoms of SIBO after treatment with PPI

  After PPI therapy, approximately 8 weeks

• Incidence of SIBO before treatment with a PPI

  Baseline

• Symptoms of SIBO before treatment with a PPI

  Baseline

Study Arms (1)

Breath Test Evaluation for SIBO

EXPERIMENTAL

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).

Other: Breath Testing

Interventions

Breath Testing OTHER

Subjects drink a small carbohydrate solution, and then provide a breath sample every 15 minutes for one hour, and then every 30 minutes for the next two hours

Breath Test Evaluation for SIBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Predominant symptoms of gastroesophageal reflux disease including heartburn, regurgitation
• Subjects must be able to give appropriate informed consent

You may not qualify if:

• Prior diagnosis of SIBO
• Use of PPIs or H2R-anatagonstists in the prior 3 months
• Major concomitant illness (renal, hepatic, rheumatologic or cardiovascular disease, or malignancy)
• Antibiotic therapy within one month
• Prior gastrointestinal surgery including esophageal, gastric, and small or large bowel surgery
• Previously diagnosed irritable bowel syndrome or inflammatory bowel disease
• Individuals who are pregnant or breast feeding
• Patients with plans to become pregnant
• Inability to take PPIs, including allergy/sensitivity

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andree Koop, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: November 17, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)