ClinicalTrials.gg
RecruitingNCT05976165Updated Feb 12, 2026

A Study of Breath Testing for Small Intestinal Bacterial Overgrowth

An interventional study of Breath Testing in Gastroesophageal Reflux, Regurgitation and Heartburn, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Gastroesophageal Reflux
  • Regurgitation
  • Heartburn

Keywords

  • Proton pump inhibitor
03

In context

Gastroesophageal Reflux

1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.

This study's planned enrollment of 50 is below the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 )
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study 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).

    Other: Breath Testing

Interventions

  • OtherBreath 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

06

What researchers measure

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 ).

    Time frame: After PPI therapy, approximately 8 weeks

Secondary outcomes

  1. 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.

    Time frame: After PPI therapy, approximately 8 weeks

  2. 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 ).

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05976165
Lead sponsor
Mayo Clinic
Responsible party
Andree H. Koop (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Aug 4, 2023
Start date
Nov 17, 2023
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Feb 12, 2026

Study contacts

Andree Koop, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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