Xylitol Clinical Trials

Size	Price	Qty
100mg	USD 147

Clinical Trials

A completed Phase 2/3 clinical trial, co-sponsored by Ochsner Health System and the Tulane University School of Medicine, evaluated the therapeutic efficacy of topical xylitol irrigation. The study investigated its use in treating recalcitrant chronic rhinosinusitis, sinusitis, bacterial overgrowth, and biofilm formation, particularly in the context of endoscopic sinus surgery and sinus drainage. This research provides key clinical evidence regarding xylitol's role in addressing persistent upper respiratory inflammatory conditions and sinus microbial burdens.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03229551	Completed	Chronic Rhinosinusitis\|Rhinosinusitis\|Sinusitis\|Drain Sinus\|Endoscopic Sinus Surgery\|Biofilms\|Bacterial Overgrowth	Ochsner Health System\|Tulane University School of Medicine	2018-03-01	Phase 2\|Phase 3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Xylitol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Xylitol is taken up by susceptible bacterial cells and converted into non-metabolizable xylitol-5-phosphate, which inhibits key glycolytic enzymes and disrupts downstream intracellular carbohydrate transport. This biochemical blockade depletes microbial cellular energy reserves and suppresses extracellular polysaccharide production, leading to inhibited bacterial proliferation and disrupted biofilm formation in chronic rhinosinusitis and bacterial overgrowth.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).