Xylitol vs Saline Nasal Irrigations in CF-CRS

Enrolling by invitation · Not applicable

Conditions studied: Chronic Rhinosinusitis (Diagnosis)

In brief

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.

Key facts

Study ID

NCT05531630

Run by

Universitaire Ziekenhuizen KU Leuven

People needed

38

Starts

2022-12-01

Expected to finish

2026-12-30

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients <18 years old
• Start of CFTR gene-modulator less than 6 months prior to inclusion
• Not willing to participate in this trial or incompliant to the trial
• 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)

Where it is running

• KU Leuven — Leuven, Belgium

Full record on ClinicalTrials.gov

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