Lactose Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials investigate lactose and its metabolic roles in conditions including lactose intolerance, endothelial dysfunction, and pediatric pyruvate kinase deficiency with pediatric hemolytic anemia. Ranging from non-applicable phases to Phase III, these completed or recruiting studies assess diagnostic breath metabolomics, gastrointestinal outcomes in rowers, and pediatric anemia treatments. Academic sponsors such as ETH Zurich, the University of Zurich, and Poznan University of Physical Education, along with industry sponsors like Agios Pharmaceuticals Inc., support these initiatives.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06177938	Recruiting	Lactose Intolerance	ETH Zurich\|Agroscope Liebefeld-Posieux Research Station ALP\|Swiss Allergy Centre\|University of Zurich	2024-01	Not Applicable
NCT06403241	Completed	Endothelial Dysfunction	Poznan University of Physical Education	2023-05-01	--
NCT05175105	Recruiting	Pediatric Pyruvate Kinase Deficiency\|Pediatric Hemolytic Anemia	Agios Pharmaceuticals Inc.	2022-06-06	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lactose functions as a disaccharide substrate that binds brush-border lactase-phlorizin hydrolase, undergoing enzymatic cleavage into glucose and galactose to enable intestinal transport and cellular energy metabolism. In lactase-deficient states, intact lactose passes into the colon where microbial fermentation produces organic acids and gases, inducing osmotic fluid shift and gastrointestinal symptoms central to clinical diagnoses of lactose intolerance.

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>).