Sucralose Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Several clinical trials evaluate the biological and physiological impacts of sucralose on enteric hyperoxaluria, inflammatory bowel disease, and maternal breastfeeding parameters. Sponsored by academic and government institutions such as NYU Langone Health, the National Institute of Diabetes and Digestive and Kidney Diseases, Rush University Medical Center, and George Washington University, all protocols carry a phase designation of Not Applicable. Ranging in recruitment status from recruiting to active, not recruiting, these investigations examine the gut-kidney axis, intestinal barrier homeostasis, and the intergenerational transfer of low-calorie sweeteners.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05124886	Recruiting	Enteric Hyperoxaluria	NYU Langone Health\|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2022-11-10	Not Applicable
NCT05579392	Recruiting	Inflammatory Bowel Disease	Rush University Medical Center	2022-09-22	Not Applicable
NCT05379270	Active not recruiting	Breastfeeding	George Washington University	2022-02-28	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sucralose selectively binds to the heterodimeric sweet taste receptor TAS1R2/TAS1R3 on lingual and intestinal enteroendocrine cells, triggering G-protein-coupled receptor signaling while resisting enzymatic cleavage in the human digestive tract. This non-metabolized activation alters downstream nutrient-sensing cascades and epithelial transport without providing metabolic energy, making it a valuable non-caloric tracer for evaluating intestinal barrier function, gut-kidney crosstalk, and maternal transmission in clinical studies of inflammatory bowel disease and enteric hyperoxaluria.

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>).