D-(+)-Raffinose pentahydrate Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial is currently recruiting pediatric patients with peanut and nut allergies to evaluate the therapeutic potential of a raffinose-containing, immune-supportive diet on intestinal permeability and allergic responses. Sponsored by academic institutions and medical centers, including Onze Lieve Vrouwe Gasthuis, Erasmus Medical Center, and Wageningen University, this non-applicable phase study investigates how functional dietary oligosaccharides modulate gut barrier integrity and alleviate hypersensitivity symptoms.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05667610	Recruiting	Peanut Allergy\|Nut Allergy	Onze Lieve Vrouwe Gasthuis\|Ekhaga foundation\|Rijnstate Hospital\|Noordwest Ziekenhuisgroep\|Erasmus Medical Center\|Wageningen University\|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	2022-09-08	Not Applicable

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

Check the D-(+)-Raffinose pentahydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a non-digestible trisaccharide comprising galactose, glucose, and fructose, D-(+)-raffinose selectively feeds beneficial gut microflora to stimulate short-chain fatty acid biosynthesis and suppress downstream pro-inflammatory signaling pathways. This strengthening of the mucosal epithelial barrier and attenuation of immune reactivity provides a mechanistic foundation for mitigating gastrointestinal permeability in clinical conditions such as peanut allergy and nut allergy.

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>).