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Could a healthy Person's nose bacteria cure sinusitis?

NCT ID NCT07184684

Disease control Sponsor: Region Skane Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether transplanting nasal bacteria from a healthy donor can relieve chronic sinusitis. Fifty adults with sinusitis will receive either the bacteria rinse or a placebo for five days. The goal is to see if symptoms improve and if the nasal microbiome becomes healthier.

What this could mean

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

Active substance
sinonasal microbiome transplant (nasal lavage from a healthy donor)
What this could lead to
If it works, this could offer a new, non-surgical treatment for chronic sinusitis by restoring a healthy nasal microbiome.
What could go wrong
This is an early phase 2/3 trial with only 50 people. The previous pilot was small, and the placebo effect is strong in sinusitis studies. The treatment requires daily nasal rinses for five days, which may be inconvenient.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Feb 2031

An estimate. End dates often move.

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.

Ages

18 years and older

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 (CRS-Patients): * 2 nasal symptoms, 1 of which must be nasal obstruction or discolored discharge. * Sinusitis verified by endoscopy or CT scan * Duration \> 12 weeks. * Signed informed consent to participate in the study. Exclusion Criteria (CRS-Patients): * Antibiotic treatment in the last 3 months before study start. * Ongoing or recent participation in another clinical trial. * Any medication that might affect the results in an unpredictable manner. * Treatment with monoclonal antibodies (biologics). * Immunodeficiency other than low grade MBL deficiency. * Pregnancy or breastfeeding * Severe anatomical abnormalities. * SNOT 22 \< 20. Inclusion Criteria (Donors): * No history of sinonasal or lower airway disease within the last two years other than the common cold. * Accepted as a donor by the patient. * Signed informed consent to participate in the study. Exclusion Criteria (CRS-Patients): * Chronic rhinosinusitis. * Acute rhinosinusitis within the last two years. * Nasal polyposis * Antibiotic treatment within the last 3 months before the study start. * On going or recent participation in another clinical trial. * Findings in the pre study scan that makes the donor unsuitable.

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Conditions

The condition(s) this trial relates to.

chronic rhinosinusitis

As listed by the trial registrant

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

Chronic rhinosinusitis with nasal polyps Chronic rhinosinusitis without nasal polyps

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Departement of ORL

    RECRUITING

    Helsingborg, 25187, Sweden

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