Gastroesophageal RefluxNCT05976165
A Study of Breath Testing for Small Intestinal Bacterial Overgrowth
A study testing Breath Testing in people with Gastroesophageal Reflux and Regurgitation, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers hope to determine how often small intestinal bacterial overgrowth occurs after taking proton pump inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux, Regurgitation, Heartburn
- What is being tested?
- Breath Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2023to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Predominant symptoms of gastroesophageal reflux disease including heartburn, regurgitation
- Subjects must be able to give appropriate informed consent
Who cannot join
- 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
Show all 9Show fewer
- Individuals who are pregnant or breast feeding
- Patients with plans to become pregnant
- Inability to take PPIs, including allergy/sensitivity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Andree H Koop, MD, 9049533970, koop.andree@mayo.edu
About this study
Official title: Breath Testing for Small Intestinal Bacterial Overgrowth in Patients Treated With Proton Pump Inhibitors
Researchers hope to determine how often small intestinal bacterial overgrowth occurs after taking proton pump inhibitors.
- Conditions
- Gastroesophageal Reflux, Regurgitation, Heartburn
- Being tested
- Breath Testing
- Keywords
- Proton pump inhibitor
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath TestingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Breath Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ).
Measured: After PPI therapy, approximately 8 weeks
Secondary outcomes (3)
Symptoms of SIBO after treatment with PPI
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.
Measured: After PPI therapy, approximately 8 weeks
Incidence of SIBO before treatment with a PPI
Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) before clinical treatment of proton pump inhibitors (PPI ).
Measured: Baseline
Symptoms of SIBO before treatment with a PPI
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start17 Nov 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andree H. Koop, Mayo Clinic
- Investigators
- Andree Koop, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976165
- Sponsor's protocol ID
- 22-007268
- Status last verified
- Feb 2026
- First submitted
- 27 Jul 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Testing for Small Intestinal Bacterial Overgrowth in Patients Treated With Proton Pump Inhibitors
- ClinicalTrials.gov ID
- NCT05976165
- Acronym / sponsor ID
- 22-007268
- Conditions
- Gastroesophageal Reflux, Regurgitation, Heartburn
- Keywords
- Proton pump inhibitor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers hope to determine how often small intestinal bacterial overgrowth occurs after taking proton pump inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breath Test Evaluation for SIBO | Experimental | Other: Breath TestingSubjects 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Predominant symptoms of gastroesophageal reflux disease including heartburn, regurgitation
- Subjects must be able to give appropriate informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath TestingSubjects 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 | Other | Breath Test Evaluation for SIBO |
Primary outcome
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 ).
3 secondary outcomes
Symptoms of SIBO after treatment with PPI
Time frame: After PPI therapy, approximately 8 weeks
Incidence of SIBO before treatment with a PPI
Time frame: Baseline
Symptoms of SIBO before treatment with a PPI
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andree Koop, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath Testing in people with Gastroesophageal Reflux and Regurgitation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of SIBO after treatment with PPI (time frame: After PPI therapy, approximately 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.