Inulin Clinical Trials

Size	Price	Qty
10mg	USD 70
50mg	USD 117

Clinical Trials

A clinical trial is currently investigating the physiological applications of inulin, focusing on healthy human volunteers to establish a proof-of-concept method for measuring the intestinal production of short-chain fatty acids. Currently active but not recruiting, the study's developmental phase is classified as Not Applicable. The research is supported by academic and government sponsors, namely Indiana University and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05254340	Active not recruiting	Healthy	Indiana University\|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2021-08-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an indigestible fructosan carbohydrate, inulin resists enzymatic degradation in the upper gastrointestinal tract and undergoes complete glomerular filtration without renal tubular secretion or reabsorption. This unique physiological handling allows inulin to serve as a precise diagnostic marker for kidney clearance and a substrate for assessing short-chain fatty acid metabolism in healthy trial participants.

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>).