Xylitol vs Saline Nasal Irrigations in CF-CRS (NCT05531630) | Clinical Trial Compass
By InvitationNot Applicable
Xylitol vs Saline Nasal Irrigations in CF-CRS
Belgium38 participantsStarted 2022-12-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Visual analogue scale for total sinus symptom