Recruiting

Breath Testing

Sponsor:

Mayo Clinic

Code:

NCT05976165

Conditions

Gastroesophageal Reflux

Regurgitation

Heartburn

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Breath Testing

Study Details

Brief summary:

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

Conditions

Gastroesophageal Reflux

Regurgitation

Heartburn

Study ID

NCT05976165

Start date

Nov 17, 2023

Status verified date

Feb, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

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

Exclusion criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Breath Test Evaluation for SIBO

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).

Interventions

Breath Testing

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

Primary outcome measure

  • Incidence of SIBO after treatment with PPI [ Time Frame: After PPI therapy, approximately 8 weeks ]

Central Contacts and Locations

Locations

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Andree H Koop, MD

9049533970koop.andree@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Proton pump inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-12.