Clinical Trials

Several clinical trials evaluate conditions associated with indole metabolic pathways, all categorized under a phase designation of Not Applicable. Spanning both recruiting and completed protocols, these studies address chronic kidney disease, renal failure, celiac disease related to altered tryptophan metabolism, spinal cord injuries, polytrauma, burns, and dietary biomarkers. Sponsored by institutions such as McMaster University, Charité University Berlin, Chalmers University of Technology, and the European Commission Horizon 2020, specific investigations evaluate continuous flow peritoneal dialysis systems and microbiota-mediated aryl hydrocarbon receptor signaling via tryptophan supplementation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06314503 Recruiting
Renal Insufficiency Chronic|Kidney Failure Chronic|Chronic Kidney Diseases
UMC Utrecht|European Commission Horizon 2020|Dutch Kidney Foundation|Health Holland|Nanodialysis Ltd|Università degli studi di Modena e Reggio Emilia (UNIMORE)|Servicio Madrileno De Salud (SERMAS)|PPI Healthcare Consulting Ltd
 2024-01-22 Not Applicable
NCT05576038 Recruiting
Tryptophan Metabolism Alterations|Celiac Disease
McMaster University
 2022-12-01 Not Applicable
NCT05351333 Recruiting
Spinal Cord Injuries|Polytrauma|Burns
Spaulding Rehabilitation Hospital|National Institute on Drug Abuse (NIDA)
 2022-08-03 Not Applicable
NCT05071131 Recruiting
Chronic Kidney Disease 5D
Charite University Berlin Germany
 2022-02-01 Not Applicable
NCT05073523 Completed
Healthy
Chalmers University of Technology
 2021-09-27 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an aromatic heterocyclic bacterial metabolite derived from tryptophan, indole binds and activates host signaling targets such as the aryl hydrocarbon receptor to modulate downstream transcriptional programs involved in epithelial homeostasis and immune regulation. Consequently, this signaling enhances mucosal tight junction integrity and attenuates inflammatory responses, offering clinical relevance for restoring impaired tryptophan metabolism in celiac disease and managing uremic toxin dynamics in chronic kidney disease.

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.