Clinical Trials

Multiple clinical trials sponsored by academic and medical institutions, including the Mayo Clinic and the University of Copenhagen, investigate the diagnostic and physiological applications of xylose in conditions such as small intestinal bacterial overgrowth syndrome, postprandial hyperglycemia, insulin resistance, eosinophilic esophagitis, colorectal tumors, and chronic obstructive pulmonary disease-associated gastrointestinal absorption. Emphasizing diagnostic testing and metabolic monitoring, most of these studies carry unassigned or non-applicable phase classifications. Recruitment statuses across the portfolio vary, comprising completed, terminated, and unverified investigations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05136092 COMPLETED
Colorectal Tumors
Weill Medical College of Cornell University
 2022-02-16
NCT03243994 COMPLETED
Chronic Obstructive Pulmonary Disease; Cor Pulmonale
Jens Rikardt Andersen
 2016-02-01
NCT02314455 TERMINATED
Eosinophilic Esophagitis
Mayo Clinic
 2014-09
NCT03243994 Completed
Chronic Obstructive Pulmonary Disease|Cor Pulmonale
Jens Rikardt Andersen|University of Copenhagen
 2016-02-01 Not Applicable
NCT01762579 RECRUITING
Not-celiac Wheat Sensitivity
University of Palermo
 2012-01-01
NCT02654301 COMPLETED
Postprandial Hyperglycemia
Yonsei University
 2014-06
NCT02314455 Terminated
Eosinophilic Esophagitis
Mayo Clinic
 2014-09 Not Applicable
NCT01762566 COMPLETED
Not-celiac Gluten (Wheat) Sensitivity
University of Palermo
 2012-01
NCT01760772 Unknown status
Heart Disease
David Dalessio|University of Cincinnati
 2013-02 Not Applicable
NCT01957098 COMPLETED
Insulin Resistance
University of Copenhagen
 2006-10

(data from https://clinicaltrials.gov, updated on 2024-11-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an aldopentose sugar, xylose interacts with specific intestinal carbohydrate transporters and metabolic enzymes, inhibiting downstream disaccharide hydrolysis and reducing transepithelial sugar transport. This cellular suppression of carbohydrate absorption lowers systemic glucose influx, providing direct clinical utility in assessing intestinal mucosal integrity and managing conditions such as postprandial hyperglycemia and small intestinal bacterial overgrowth.

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.