Breath control: a new hope for ulcerative colitis flares?
NCT ID NCT05892159
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a 5-week heart rate variability biofeedback program can reduce symptoms in people with ulcerative colitis who are currently having a flare but show no active inflammation. Twenty-three adults will practice daily breathing exercises using a device and be followed for 17 weeks. The goal is to see if this mind-body technique can improve symptom severity scores.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRV biofeedback (a behavioral technique using a device to help control breathing and heart rate)
- What this could lead to
- If it works, this could point toward a simple, drug-free way to manage ulcerative colitis symptoms during flares.
- What could go wrong
- This is a very small, early study with only 23 people, so results may not apply to everyone. It also only targets symptoms, not the underlying inflammation.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 23 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult subjects (18-65 years old) * Ulcerative colitis with a symptomatic flare (SCCAI ≥3) and without inflammation (FC\<250µg/ml) Exclusion Criteria: * Individuals who take medications known to alter heart rate variability * Individuals with pacemakers or other implantable devices
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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