What side effects are associated with this type of intervention?

The most common treatments for Small Bowel Bacterial Overgrowth (SIBO) include antibiotics, probiotics, and dietary changes. Antibiotics, such as rifaximin, can cause side effects like nausea, abdominal pain, and diarrhea. Probiotics are generally well-tolerated but can occasionally lead to bloating and gas. Dietary changes, such as a low FODMAP diet, may result in nutritional deficiencies if not properly managed. These treatments aim to reduce bacterial overgrowth and alleviate symptoms, but they must be tailored to individual patient needs to minimize adverse effects.

What prior FDA approvals exist?

The FDA has approved rifaximin for the treatment of irritable bowel syndrome with diarrhea (IBS-D), and it is frequently used off-label for Small Bowel Bacterial Overgrowth Syndrome (SIBO). Other antibiotics such as metronidazole and ciprofloxacin are also commonly used off-label to treat SIBO. These treatments aim to reduce the bacterial overgrowth in the small intestine, which is often diagnosed using hydrogen breath tests.

What other types of research exist?

One promising alternative to AIRE for diagnosing SIBO is the use of fecal volatile organic compounds (VOCs) analysis. This method involves using an electronic nose device to detect specific VOCs in fecal samples, which can serve as non-invasive biomarkers for gastrointestinal conditions. Another potential alternative is the hydrogen breath test with lactulose, although its accuracy is limited. These methods offer non-invasive options for assessing gastrointestinal health and could be considered for SIBO diagnosis and management.

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Diagnostic Device

Hydrogen Breathalyzer for Small Intestinal Bacterial Overgrowth (AIRE Trial)

N/A

Waitlist Available

Led By Pankaj Pasricha, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (18 years of age or older)

Chronic (>3 months) GI symptoms such as nausea, bloating, distention, altered bowel movements, weight loss or abdominal pain with no structural cause other than scleroderma.

Must not have

History of inflammatory bowel disease

Unable to tolerate oral intake

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at one month after negative lhbt

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a handheld device called AIRE that measures hydrogen in the breath to diagnose SIBO. It is aimed at patients suspected of having SIBO because current tests are not very accurate and are inconvenient. The device works by detecting hydrogen gas produced by bacteria in the small intestine and provides immediate results through a smartphone app.

Who is the study for?

This trial is for adults over 18 with chronic gastrointestinal symptoms like nausea, bloating, or abdominal pain and a clinical diagnosis of SIBO. Participants must be able to eat normally and use a smartphone with Bluetooth. Those on recent antibiotics, with inflammatory bowel disease, or on restrictive diets cannot join.

What is being tested?

The study tests the AIRE device, a handheld breath analyzer that measures hydrogen in breath to identify food sensitivities related to SIBO. It aims to see if this portable device can more accurately detect SIBO compared to current standard methods.

What are the potential side effects?

Since the intervention involves only recording hydrogen content using the AIRE device after consuming lactulose, there are no direct side effects from the device itself; however, lactulose ingestion may cause digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have had GI symptoms like nausea or bloating for over 3 months due to scleroderma.

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I can undergo the lactose breath test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of inflammatory bowel disease.

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I cannot eat or drink by mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at one month after negative lhbt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at one month after negative lhbt

This trial's timeline: 3 weeks for screening, Varies for treatment, and at one month after negative lhbt for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hydrogen content in parts per million (ppm)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Breath analyzerExperimental Treatment1 Intervention

Candidates who, after the screening period are eligible to receive the AIRE device.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Small Bowel Bacterial Overgrowth Syndrome (SIBO) include antibiotics and dietary interventions. Antibiotics like rifaximin and neomycin work by reducing the excessive bacterial population in the small intestine, which is essential for alleviating symptoms such as bloating, diarrhea, and malabsorption. Dietary interventions, such as a low FODMAP diet, aim to limit fermentable carbohydrates that bacteria thrive on, thereby reducing bacterial activity and associated symptoms. The AIRE study's focus on measuring exhaled hydrogen helps identify specific food sensitivities, allowing for personalized dietary management, which can significantly improve symptom control and patient quality of life.

Gastrointestinal motility disorders and bacterial overgrowth.