Clinical Trials

Several clinical trials evaluate the diagnostic and therapeutic applications of lactulose across gastrointestinal and metabolic conditions, including metabolic disturbance with increased gut permeability, irritable bowel syndrome with bile acid diarrhea, and ulcerative colitis. Sponsored by academic and industrial organizations such as Appalachian State University, AGRANA, the Mayo Clinic, and GlaxoSmithKline, these early-stage protocols encompass Phase 1 and unclassified phase designations. Recruitment statuses across this research portfolio currently range from actively recruiting to withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06392360 Recruiting
Metabolic Disturbance|Permeability; Increased
Appalachian State University|AGRANA
 2024-05-13 Not Applicable
NCT06028035 Recruiting
Irritable Bowel Syndrome-bile Acid Diarrhea
Mayo Clinic
 2023-10-06 Not Applicable
NCT05999708 Withdrawn
Colitis Ulcerative
GlaxoSmithKline
 2023-10-31 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lactulose selectively functions as a non-absorbable disaccharide substrate that ferments into short-chain fatty acids while directly inhibiting monocyte-derived tumor necrosis factor production to suppress localized inflammation. This biochemical activity enhances colonic osmotic pressure and reinforces mucosal barrier integrity, offering therapeutic benefits in constipation, hepatic encephalopathy, and inflammatory gut disorders characterized by altered intestinal permeability like ulcerative colitis and irritable bowel syndrome.

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>).

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Note: Technical data last updated: Sep 1, 2026.