NCT05531630Enrolling by invitation
Xylitol vs Saline Nasal Irrigations in CF-CRS
Xylitol Nasal Irrigations in the Treatment of Chronic Rhinosinusitis in Cystic Fibrosis Patients: a Randomized Crossover Trial
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 19 Aug 2022
- Start date
- 1 Dec 2022
- Primary completion date
- 1 Aug 2023
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Cystic fibrosis
- NCT number
- NCT05531630
What you commit to
- Study type: Interventional
- Planned participants: 38
- From 1 Dec 2022 to the primary completion date, 1 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Start of CFTR gene-modulator less than 6 months prior to inclusion
Other illness
- 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)
Age
- Patients \<18 years old
Other
- Not willing to participate in this trial or incompliant to the trial
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| KU Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.