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A breath test for gut disease? researchers hunt for invisible clues

NCT ID NCT04827368

Diagnosis Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This study tests whether chemicals in a person's breath, called volatile organic compounds, can signal inflammation in inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis. Researchers will collect breath, blood, and stool samples from people with IBD and from healthy controls. They will compare breath compounds with standard markers like fecal calprotectin and C-reactive protein to see if a non-invasive breath test could help monitor disease activity and guide treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Breath, blood, and stool sample collection for analysis of volatile organic compounds
What this could lead to
If breath compounds reliably track inflammation, patients might one day monitor IBD with a simple breath test instead of invasive procedures.
What could go wrong
This is an early observational study, so the breath compounds may not correlate strongly with disease activity. The test is not ready for clinical use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

292 people

The number who actually took part.

Started

Mar 2021

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This is a prospective, controlled, non-interventional cohort study, conducted at the Cleveland Clinic IBD Center, using serially obtained breath and serum headspace VOCs as non-invasive biomarkers to detect disease activity in IBD, fecal calprotectin, CRP, and patient-reported outcome tools. No drug will be evaluated in this study. All visits for this study as well as the initial endoscopy will be based on standard clinical practice and guidelines. At inclusion, all patients will have a colonoscopy (indication is standard of care), CRP, fecal calprotectin, and baseline PRO2 to establish the pattern for disease activity, which will subsequently be evaluated for change by using fecal calprotectin, CRP, and PRO2 over one year (every 3 months), as a surrogate marker for disease activity.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosed as having Crohn's Disease or Ulcerative Colitis * Aged 18-70 years. * Understands the language and signs an informed consent form. * Any disease location, except isolated upper GI Crohn's disease only * Any CD or UC disease activity. * Outpatients and inpatients * Patients will be recruited, and samples obtained at least one day, and no more than one week, prior to out/inpatient colonoscopy preparation to allow objective assessment of disease activity. Exclusion Criteria: * Status post colectomy * Status post diverting loop ileostomy or end ileostomy or colostomy * On antibiotics in the past 3 months or currently * Women (pregnant or breast feeding) * Subjects with concurrent chronic liver, renal, lung or metabolic disorders * Active malignancy * Bowel preparation at day of sample procurement * Isolated upper GI Crohn's disease only * Active disease on colonoscopy, but normal fecal calprotectin at inclusion * C diff. positive at time of inclusion (test to be obtained in routine clinical care).

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease IBD Ulcerative colitis

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

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