CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1 enrolled
Drug / intervention
Xylitol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03229551
NCT03229551Phase 3Completed

Xylitol Topical Irrigation for Treatment of Recalcitrant Chronic Sinusitis

Ochsner Health System·interventional·Posted Jul 25, 2017·Updated Apr 7, 2023

In Brief

A Phase 3 clinical trial evaluating Xylitol and Saline for Chronic Rhinosinusitis and 6 related conditions. Completed, enrolled 1 participant across 1 site.

Detailed Summary

The purpose of this investigation is to conduct a randomized controlled trial within a subgroup of difficult-to-treat patients with CRS, evaluating the use of topical xylitol treatment concurrently with topical steroid/antibiotics combination in the effort to disrupt biofilms and improve disease control. The effectiveness of topical surfactants is a research gap in treating CRS but has promising correlates in other medical fields. Specifically, the investigators will be studying the effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 25, 2017
Enrollment StartMar 1, 2018
Primary CompletionJul 16, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.9 years ago

Interventions

Xylitoldrug

Topical 5% Xylitol (wt/vol) diluted in saline nasal irrigant. Topical corticosteroid and antibiotic as directed by bacterial DNA sequencing results will be diluted in this irrigant and administered concurrently.

Salinedrug

Saline as a standard-of-care nasal irrigant. Topical corticosteroid and antibiotic as directed by bacterial DNA sequencing results will be diluted in this irrigant and administered concurrently.