Stevioside Clinical Trials

Size	Price	Qty
5mg	USD 107

Clinical Trials

A clinical trial is evaluating the impact of consuming stevia-sweetened beverages on oral health outcomes, specifically oral pH, the oral microbiome, and dental plaque dynamics. Sponsored by a hospital facility, the Hospital Infantil de Mexico Federico Gomez, this combined Phase 1 and Phase 2 investigation aims to clarify the localized physiological impact of stevioside on dental biofilm accumulation and microbial ecosystems. According to trial records, the study's current recruitment status is listed as not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05852145	Not yet recruiting	pH\|Microbiome\|Dental Plaque	Hospital Infantil de Mexico Federico Gomez	2023-10	Phase 1\|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Stevioside, a diterpene glycoside, acts by interacting with bacterial cell membranes and metabolic enzymes, thereby inhibiting extracellular polysaccharide synthesis and enzymatic acid production in oral microflora. This biochemical blockage suppresses bacterial acidogenesis and cellular adhesion, thereby stabilizing oral pH, preventing dental plaque accumulation, and modulating oral microbiome homeostasis.

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>).