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NCT04309396 · ClinicalTrials.gov registry record · NA
Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Food Sensitivities (AIRE Study)
A NA study of SIBO and Small Bowel Bacterial Overgrowth Syndrome, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT04309396: Completed NA study of SIBO and Small Bowel Bacterial Overgrowth Syndrome, sponsored by Johns Hopkins University.
NCT04309396 is a NA study of SIBO and Small Bowel Bacterial Overgrowth Syndrome that has completed, run by Johns Hopkins University. The registered enrollment target is 45 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04309396, a NA study of SIBO and Small Bowel Bacterial Overgrowth Syndrome, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
Small intestinal bacterial overgrowth (SIBO) is defined as a condition in which an abnormally high amount of coliform bacteria is present in the small bowel and results in premature anaerobic fermentation of carbohydrates before reaching the colon. Commonly recognized causes include gastric achlorhydria, post-surgical bowel stasis, gastrocolic/coloenteric fistulas, and motility disorders leading to bowel stasis.. The current "gold standard" for the diagnosis of SIBO, is a breath test that measures the concentration of hydrogen in response to lactulose, a carbohydrate that is only metabolized by bacteria. However, its accuracy is only about 50% and therefore it is not a very useful test, leading most physicians to treat these patients empirically based on clinical suspicion alone. The purpose of this study is to evaluate the clinical utility of a portable medical device called AIRE, an over-the-counter, commercially available handheld breath analyzer that measures exhaled hydrogen content.
Primary Outcome
Exhaled hydrogen (H2) content as measured over a 1-week period by AIRE on the patient's usual diet at home. Mean of one week readings is reported.
Conditions Studied
Interventions
- DEVICE Hydrogen content recording
Study Locations (1)
Maryland
- Johns Hopkins Bayview Medical Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2025-03-20 |
| Phase | NA |
What the finished NCT04309396 record still lists
NCT04309396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with SIBO appearing as the primary indexed condition, and to 1 intervention - of which Hydrogen content recording is the first listed.
NCT04309396 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04309396 about?
NCT04309396 is a clinical study titled "Clinical Utility of Handheld Hydrogen Breathalyzer in Identification of Food Sensitivities (AIRE Study)". Small intestinal bacterial overgrowth (SIBO) is defined as a condition in which an abnormally high amount of coliform bacteria is present in the small bowel and results in premature anaerobic fermentation of carbohydrates before reaching the colon. Commonly recognized causes include gastric achlorhy...
What is the current status of trial NCT04309396?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2020-10-01. Estimated completion is 2025-03-20.
What conditions does trial NCT04309396 study?
This clinical trial studies the following conditions: SIBO, Small Bowel Bacterial Overgrowth Syndrome.
What interventions are being tested in trial NCT04309396?
The interventions under investigation include: Hydrogen content recording (DEVICE).
Who is sponsoring clinical trial NCT04309396?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04309396 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04309396's enrollment target sits among peer trials
45 1411th of 2000 higher than 578 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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