Breath Testing for Gut Bacteria Imbalance

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: PPIs, H2R-antagonists, Antibiotics

Disqualifiers: SIBO, Major illness, GI surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the frequency of small intestinal bacterial overgrowth (SIBO) after using proton pump inhibitors (PPIs), which treat gastroesophageal reflux disease (GERD). Researchers use a simple breath test to check for SIBO. Individuals with symptoms like heartburn or regurgitation from GERD who haven't recently used PPIs might be suitable candidates. As an unphased trial, this study allows participants to contribute to important research that could enhance the understanding and treatment of GERD-related conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot have used proton pump inhibitors or H2R-antagonists in the last 3 months, and you must not have taken antibiotics in the past month.

What prior data suggests that this breath testing is safe for evaluating small intestinal bacterial overgrowth?

Research shows that breath testing is a safe and easy way to check for small intestinal bacterial overgrowth (SIBO). It is often preferred due to its simplicity and wide availability. During a breath test, a person breathes into a special device that measures gases like hydrogen and methane, which can indicate excessive bacteria in the small intestine.

One study highlighted that this method is noninvasive, meaning it doesn’t involve surgery or needles, making it a comfortable option for many people. However, while breath testing is safe, some studies mention that its accuracy can vary, and more research is needed to confirm its effectiveness in different situations.

Overall, breath testing is considered safe and well-tolerated for diagnosing SIBO. For those considering joining a trial involving breath testing, this information may clarify what to expect regarding safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about breath testing for gut bacteria imbalance because it offers a non-invasive way to diagnose small intestinal bacterial overgrowth (SIBO) in people with symptoms of GERD. Unlike traditional methods that might rely on more invasive procedures or empirical treatment with antibiotics, breath testing can quickly and easily identify SIBO by analyzing the gases produced in the breath. This method is more comfortable for patients and offers the potential for quicker diagnosis, allowing for more targeted treatment plans.

What evidence suggests that breath testing is effective for detecting small intestinal bacterial overgrowth?

Research has shown that breath tests are commonly used to diagnose small intestinal bacterial overgrowth (SIBO). In this trial, participants will undergo breath testing to evaluate for SIBO. These tests can detect SIBO, but they sometimes incorrectly indicate a problem when there isn't one, known as a false positive. The glucose breath test, in particular, often produces these false positives. Conversely, the lactulose breath test might provide more accurate results in some cases. Overall, breath tests are useful but require careful use to ensure a correct diagnosis. ^{1 6 7 8 9}

Who Is on the Research Team?

Andree Koop, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with symptoms of gastroesophageal reflux disease (GERD) like heartburn and regurgitation, who can consent to the study. It's not for those with prior GI surgery, pregnant or breastfeeding women, recent users of PPIs/H2R-antagonists or antibiotics, diagnosed IBS/IBD patients, those planning pregnancy, or unable to take PPIs due to allergies.

Inclusion Criteria

I often experience heartburn and acid reflux.

Subjects must be able to give appropriate informed consent

Exclusion Criteria

I have not taken antibiotics in the last month.

I have been diagnosed with irritable or inflammatory bowel disease.

I have had surgery on my digestive system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants undergo breath testing for SIBO before starting PPI treatment

1 week

1 visit (in-person)

Treatment

Participants receive a short course of proton pump inhibitors (PPI) and are evaluated for SIBO

8 weeks

1 visit (in-person)

Follow-up

Participants are monitored for symptoms of SIBO after PPI treatment using questionnaires

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Breath Testing

Trial Overview The study is testing breath analysis as a method to detect small intestinal bacterial overgrowth in people who have taken proton pump inhibitors. The goal is to see how common this condition is among GERD sufferers after using these medications.

How Is the Trial Designed?

Group I: Breath Test Evaluation for SIBO Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10496284/

Pros and Cons of Breath Testing for Small Intestinal ... Recent studies have demonstrated the expanding clinical utility of breath testing in the diagnosis, management, and prediction of treatment response in SIBO and ...

2. mayoclinic.org mayoclinic.org/medical-professionals/digestive-diseases/news/an-updated-appraisal-of-the-sibo-hypothesis-and-the-limits-of-breath-testing/mac-20574581

An updated appraisal of the SIBO hypothesis and the limits ... Thus, breath testing can yield false-positive results in a very high proportion of individuals. The authors explain that the glucose hydrogen ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/nmo.14817

Critical appraisal of the SIBO hypothesis and breath testing ... Scintigraphy demonstrates high rate of false-positive results from glucose breath tests for small bowel bacterial overgrowth. Clin ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210740124002031

The prevalence of small intestine bacterial overgrowth in ... This retrospective study confirmed that the positivity of lactulose breath test is 10 times higher than glucose breath test in IBS patients.

5. jnmjournal.org jnmjournal.org/journal/view.html?doi=10.5056/jnm19113

Breath Tests for the Non-invasive Diagnosis of Small ... In patients with abdominal surgery history, pooled GBT sensitivity and specificity gave the impression of having a better performance (81.7% and 78.8%) compared ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10132719/

Understanding Our Tests: Hydrogen-Methane Breath ... The gold standard test for SIBO—direct culture of small intestinal contents—is technically cumbersome, invasive, costly, and subject to some contention ...

7. commdx.com commdx.com/breath-testing-for-sibo-imo/

Breath Testing for SIBO & IMO The Hydrogen and Methane Breath Test kits for SIBO and IMO is a non-invasive diagnostic tool to identify SIBO and can be administered in the patient's own ...

8. wa-provider.kaiserpermanente.org wa-provider.kaiserpermanente.org/static/pdf/hosting/clinical/criteria/pdf/combined_hydrogen_methane_breath_test.pdf

Combined Hydrogen Methane Breath Test (SIBO) There is insufficient evidence regarding the effectiveness and safety of the trio-smart® breath test for aiding diagnosis of small intestinal bacterial ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1542356513014687

Breath Testing for Small Intestinal Bacterial Overgrowth Hydrogen breath testing provides the simplest noninvasive and widely available diagnostic modality for suspected SIBO.