Lactitol Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial sponsored by the Instituto de Investigación Hospital Universitario La Paz evaluates the therapeutic application of lactitol. This Phase 2 study investigates the management of bacterial colonization, specifically targeting intestinal decolonization in carrier patients, though its recruitment status is currently listed as unknown. Overall, clinical research on this compound represents an academic effort exploring targeted microflora interventions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02307383	Unknown status	Bacterial Colonization	Instituto de Investigación Hospital Universitario La Paz	2014-10	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lactitol functions as an indigestible disaccharide sugar alcohol that resists upper gastrointestinal enzymatic cleavage, reaching the distal gut intact to serve as a selective fermentation substrate for colonic microflora. Subsequent metabolic conversion into short-chain fatty acids reduces luminal pH and elevates osmotic pressure, which inhibits opportunistic pathogen proliferation and supports clinical strategies aimed at reducing bacterial colonization.

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>).