Clinical Trials

A clinical trial is evaluating the physiological effects of chitin on gastrointestinal health, specifically focusing on its impact on irritable bowel syndrome. Sponsored by academic institutions including Colorado State University and the University of Wisconsin-Madison, this study carries a phase designation of Not Applicable. The investigation currently maintains an active, not recruiting status while evaluating the therapeutic potential of edible insect-derived structural polysaccharides in modulating intestinal health.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06397924 Active not recruiting
Irritable Bowel Syndrome
Colorado State University|University of Wisconsin Madison
 2023-07-06 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a large structural polysaccharide, chitin functions within the gastrointestinal tract as a non-digestible dietary fiber that alters mucosal dynamics and selective microbial colonization. The subsequent microbial fermentation generates bioactive short-chain fatty acids that modulate local immune responses and improve gut barrier integrity, providing a mechanistic rationale for addressing gastrointestinal inflammation in conditions like 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.