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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at one month after negative lhbt
Awards & highlights

AIRE Trial Summary

This trial will determine if a portable medical device called AIRE is a useful tool for diagnosing SIBO.

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.Check my eligibility
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.See study design
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.

AIRE Trial 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.
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I can eat and drink without assistance.
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My doctor suspects I have SIBO and plans to confirm it with a breath test.

AIRE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hydrogen content in parts per million (ppm)

AIRE 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.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,242 Previous Clinical Trials
14,816,592 Total Patients Enrolled
FoodMarbleUNKNOWN
Pankaj Pasricha, MDPrincipal InvestigatorJohns Hopkins University
6 Previous Clinical Trials
277 Total Patients Enrolled

Media Library

AIRE (Diagnostic Device) Clinical Trial Eligibility Overview. Trial Name: NCT04309396 — N/A
Small Bowel Bacterial Overgrowth Syndrome Research Study Groups: Breath analyzer
Small Bowel Bacterial Overgrowth Syndrome Clinical Trial 2023: AIRE Highlights & Side Effects. Trial Name: NCT04309396 — N/A
AIRE (Diagnostic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04309396 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being enrolled in this experiment?

"Yes, as per the clinicaltrials.gov data, this medical study is currently recruiting participants. Launched on October 1st 2020 and updated most recently on March 8th 2022, it seeks 30 patients from a single site."

Answered by AI

Are there still openings for individuals to join this study?

"Affirmative. According to information published on clinicaltrials.gov, this medical trial is actively recruiting participants since its original posting on October 1st 2020 and the most recent update made in March 8th 2022. The research requires 30 volunteers at a single location."

Answered by AI
~7 spots leftby Oct 2024