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Xylitol for Chronic Sinusitis

NCT03229551 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-04-07

No results posted yet for this study

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.

Conditions

  • Chronic Rhinosinusitis
  • Rhinosinusitis
  • Sinusitis
  • Drain Sinus
  • Endoscopic Sinus Surgery
  • Biofilms
  • Bacterial Overgrowth

Interventions

DRUG

Xylitol

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.

DRUG

Saline

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.

Sponsors & Collaborators

  • Tulane University School of Medicine

    collaborator OTHER

  • Ochsner Health System

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-07-16
Completion
2018-07-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03229551 on ClinicalTrials.gov