Comparing Xylitol and Saline Nasal Rinses for Sinus Disease in Cystic Fibrosis
Tests xylitol nasal rinses against saline rinses in adults with cystic fibrosis and sinus disease.
Plain-language title generated from the registry record
Registry title: Xylitol vs Saline Nasal Irrigations in CF-CRS
Key facts
- Where
- Leuven, BelgiumSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cystic fibrosis who also have long-lasting nose and sinus inflammation (chronic rhinosinusitis) with clear nose or sinus symptoms. It compares nasal rinses with and without xylitol.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Cystic fibrosis with chronic rhinosinusitis, with or without nasal polyps. At least one nose or sinus symptom must score above 30 out of 100 on a symptom scale (blocked nose, runny nose, postnasal drip, facial pain or pressure, reduced smell).
- Earlier treatment
- People who started a CFTR gene-modulator less than 6 months before joining cannot join.
Main reasons for not taking part
- Under 18 years old
- Started a CFTR gene-modulator less than 6 months before joining
- Severe nosebleed in the last 6 months that needed treatment by an ear, nose and throat specialist
- Allergic reaction to an ingredient of the rinse sachets (NaCl, bicarbonate, mint, xylitol)
- Not willing to take part or not following the trial rules
Read by machine on 12 November 2026.
Where in Belgium
- KU LeuvenLeuven, BelgiumNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Universitaire Ziekenhuizen KU Leuven
- Trial code
- NCT05531630
- Record updated
- 1 May 2026
- Original description
Cystic fibrosis (CF) is the most common genetic disorder in Belgium, affecting 1 in 2850 children. A defect in the CFTR channel results in increased viscosity of extracellular secretions and decreased mucociliary clearance in the airways. As a result of this mechanism, chronic rhinosinusitis (CRS) occurs in nearly 100% of CF patients. CRS can lead to pronounced sinonasal complaints and can have a negative impact on the quality of life. In addition, several studies have shown that poor upper airway control has a negative impact on the lower airways. Unfortunately, treatment options are limited. Our previous study has shown that only 21% of patients have well-controlled CRS.Read full original descriptionShow less
Xylitol Nasal Irrigations in the Treatment of Chronic Rhinosinusitis in Cystic Fibrosis Patients: a Randomized Crossover Trial
Cystic fibrosis (CF) is the most common genetic disorder in Belgium, affecting 1 in 2850 children. A defect in the CFTR channel results in increased viscosity of extracellular secretions and decreased mucociliary clearance in the airways. As a result of this mechanism, chronic rhinosinusitis (CRS) occurs in nearly 100% of CF patients. CRS can lead to pronounced sinonasal complaints and can have a negative impact on the quality of life. In addition, several studies have shown that poor upper airway control has a negative impact on the lower airways. Unfortunately, treatment options are limited. Our previous study has shown that only 21% of patients have well-controlled CRS.
The aim of this single-center, randomized cross-over study is to compare the effect of nasal rinses with (XNI) and without (SNI) Xylitol in the treatment of CF-CRS. Xylitol is a sugar alcohol that is already used as an antibiofilm agent,eg in the prevention of caries. Previous pilot studies have already shown a beneficial effect of XNI in the treatment of non-CF CRS.
Inclusion: Patients with established diagnosis of cystic fibrosis > 18 years old; Routine follow-up at UZ Leuven; Patients with established diagnosis of chronic rhinosinusitis, with or without nasal polyps, and with a VAS-score of >30 out of 100 for at least one individual sinonasal symptom (nasal obstruction, rhinorrhea, postnasal drip, facial pain/pressure, reduced smell); Willing to participate in this study and compliant to the treatment.
Exclusion: Start of CFTR gene-modulator less than 6 months prior to inclusion; History of severe epistaxis (<6 months), requiring intervention by an ENT specialist; History of hypersensitivity/allergic reaction/anaphylactic shock to one of the compounds of the sachets (NaCl, bicarbonate, mint, Xylitol); Patients <18 years old; Not willing to participate in this trial or incompliant to the trial.