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

Trial Summary

What is the purpose of this trial?

This trial aims to find out how often patients taking proton pump inhibitors experience an increase in small intestinal bacterial overgrowth.

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 data supports the effectiveness of the treatment Breath Testing for gut bacteria imbalance?

Breath testing is effective in diagnosing small intestinal bacterial overgrowth (SIBO) and intestinal methanogen overgrowth (IMO), helping tailor antibiotic therapy and predict treatment response. It is a non-invasive method that measures exhaled gases to identify gut bacteria imbalances, and has been shown to be useful in managing these conditions. ^{1 2 3 4 5}

Is breath testing for gut bacteria imbalance safe for humans?

Breath tests are generally considered safe and non-invasive, even for children and pregnant women. They are used to diagnose various conditions like bacterial overgrowth and lactose intolerance without the use of radiation. ^{1 5 6 7 8}

How does breath testing for gut bacteria imbalance differ from other treatments?

Breath testing for gut bacteria imbalance is unique because it is a non-invasive method that helps diagnose conditions like small intestinal bacterial overgrowth (SIBO) and intestinal methanogen overgrowth (IMO) by analyzing the gases in your breath. Unlike other diagnostic methods, it can tailor antibiotic therapy and predict treatment response, although it has limitations due to its indirect measurement approach. ^{1 5 9 10 11}

Research Team

Andree Koop, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Pros and Cons of Breath Testing for Small Intestinal Bacterial Overgrowth and Intestinal Methanogen Overgrowth. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Understanding Our Tests: Hydrogen-Methane Breath Testing to Diagnose Small Intestinal Bacterial Overgrowth. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Monitoring and antibacterial treatment for postoperative bacterial overgrowth in Crohn's disease. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Breathing new life into clinical testing and diagnostics: perspectives on volatile biomarkers from breath. [2022]

5. Austria pubmed.ncbi.nlm.nih.gov

[Possibilities and limits of the H2 breath test]. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Breath volatile organic compounds for the gut-fatty liver axis: promise, peril, and path forward. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Using breath tests wisely in a gastroenterology practice: an evidence-based review of indications and pitfalls in interpretation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Increased Fecal Lactobacillus Is Associated With a Positive Glucose Hydrogen Breath Test in Bangladeshi Children. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the rice breath hydrogen test for small intestinal bacterial overgrowth. [2019]

10. Australia pubmed.ncbi.nlm.nih.gov

Clinical significance of the glucose breath test in patients with inflammatory bowel disease. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

Use of the lactose-[13C]ureide breath test for diagnosis of small bowel bacterial overgrowth: comparison to the glucose hydrogen breath test. [2021]