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NCT Number: NCT05976165

A Study of Breath Testing for Small Intestinal Bacterial Overgrowth

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

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Heartburn Pathological Conditions, Signs and Symptoms Regurgitation Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

Andree H Koop, MD

CONTACT

[email protected]

9049533970

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Incidence of SIBO after treatment with PPI

    Time frame: 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 outcomes

  1. Symptoms of SIBO after treatment with PPI

    Time frame: 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.

  2. Incidence of SIBO before treatment with a PPI

    Time frame: Baseline

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

  3. Symptoms of SIBO before treatment with a PPI

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Breath Testing for Small Intestinal Bacterial Overgrowth in Patients Treated With Proton Pump Inhibitors

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2023
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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