Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 12 adults who used a hypertonic seawater-based nasal spray called Healsea® Chronic, which also contains a natural extract called Symbiofilm®. All 12 participants completed the study. The trial was measuring changes in the nasal microbiome (the community of bacteria living inside the nose and sinuses) after 30 days of using the spray, as well as participants' quality of life and satisfaction with the product. It is worth noting that only 3 of the 12 participants were included in the strictest analysis group (called the "Per Protocol Set"), which means the majority did not fully meet all the study's pre-set criteria for that analysis. The reported data shows that the primary measure — a score called the Shannon Index, which estimates the variety and balance of bacterial species in the nose — was 2.041 at the start of the study and 2.114 after 30 days of treatment, representing a very small numerical change. For quality of life, participants completed a standardised nasal symptom questionnaire (the SNOT-22, where higher scores indicate more bothersome symptoms). The reported data shows the average score started at 59.3 and dropped to 41.8 after 30 days, a change of −17.5 points. The study noted that a change greater than −9 points was considered potentially meaningful by their chosen benchmark. Regarding satisfaction with ease of use (usability), all 12 participants selected the most positive rating available. For taste, 8 out of 12 chose a neutral rating, 3 chose a positive rating, and 1 chose the most positive rating. For their perception of the product's cleansing and moistening effect, 2 participants chose a neutral rating, 6 chose a positive rating, and 4 chose the most positive rating. No data was reported for the adverse events outcome measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 32077450) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Chronic Rhinosinusitis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 18 and 70 years old (male or female)
- You are willing and able to sign a consent form agreeing to take part in the study
- You are able and willing to follow all study procedures and attend for the full length of the study
- You have been diagnosed with chronic rhinosinusitis (a long-term condition causing inflammation of the sinuses and nasal passages) according to recognised medical guidelines
- You are covered by a social security or health insurance scheme
Who may not be able to join:
- You have taken antibiotics or steroid tablets by mouth in the month before the study starts
- You have had surgery on your sinuses using a camera (endoscopic sinus surgery) in the last 6 months
- You have cystic fibrosis
- You have a condition called Wegener's granulomatosis (a rare inflammatory disease affecting blood vessels)
- You have a weakened or impaired immune system
- You have a blockage or problem that prevents access to a specific area inside your nose called the middle meatus (confirm with trial site)
- You are allergic to lidocaine (a local anaesthetic)
- You have a known allergy or sensitivity to any part of the device being tested in this study
- You are pregnant, breastfeeding, or not using effective contraception (if applicable)
- You are currently under legal guardianship or tutorship
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Comparaison of Alpha-diversity of Sino-nasal Microbiota Before and After Treatment (Visit 1 and Visit 2)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.