Clinical Trials

Multiple clinical trials evaluate bismuth subcitrate potassium, primarily focusing on Helicobacter pylori infections, antibiotic-resistant bacterial strains, dysbiosis, and gastrointestinal conditions such as dyspepsia and chemotherapy-induced effects. Ranging from Phase 2 through Phase 4 alongside unassigned-phase studies, these trials feature recruitment statuses spanning completed, actively recruiting, enrolling by invitation, and not yet recruiting. The research encompasses diverse sponsors, including academic universities, regional medical centers, public health institutes, and pharmaceutical companies such as Forest Laboratories.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06509139 ENROLLING_BY_INVITATION
Helicobacter Pylori Infection; Sex; Bismuth Quadruple Therapy
National Cheng-Kung University Hospital
 2024-07-09 PHASE4
NCT04527055 ENROLLING_BY_INVITATION
Helicobacter Pylori Infection; Dysbiosis; Probiotics
National Cheng-Kung University Hospital
 2020-05-06 PHASE4
NCT07729293 NOT_YET_RECRUITING
Helicobacter Pylori Infection; Dyspepsia; Gastrointestinal Adverse Effects
Gala Servicios Clinicos S.L.
 2026-08-31
NCT07746934 NOT_YET_RECRUITING
Helicobacter Pylori Infection
University of Medicine and Pharmacy at Ho Chi Minh City
 2026-07-27
NCT06510010 RECRUITING
Chemotherapy Effect
Sixth Affiliated Hospital, Sun Yat-sen University
 2024-12-31 PHASE2
NCT06143124 UNKNOWN
Helicobacter Pylori Infection
University Medical Centre Ljubljana
 2022-03-03 PHASE4
NCT04359966 UNKNOWN
Helicobacter Pylori Infection; Eradication Treatments
Slovenian Society for Gastroenterology and Hepatology
 2020-05-10
NCT04853875 COMPLETED
Helicobacter Pylori Infection
Mackay Memorial Hospital
 2021-04-19 PHASE4
NCT04101708 UNKNOWN
Helicobacter Pylori
Shandong University
 2019-09-20 PHASE4
NCT04107194 UNKNOWN
Helicobacter Pylori Infection; Antibiotic Resistant Infection; Antibiotic Resistant Strain
University of Bari
 2020-01-14 PHASE3
NCT03925818 TERMINATED
Helicobacter Pylori Infection
Università degli Studi di Sassari
 2017-08-29
NCT02894268 UNKNOWN
Helicobacter Pylori Infection
Sir Run Run Shaw Hospital
 2016-02 PHASE4
NCT01876108 COMPLETED
Fatty Liver; Liver Dysfunction; Insulin Resistance
Tehran University of Medical Sciences
 2012-07 PHASE2
NCT01335334 UNKNOWN
H. Pylori Infection
The University of Texas Health Science Center, Houston
 2011-03 PHASE4
NCT00669955 COMPLETED
Helicobacter Infections
Forest Laboratories
 2008-06 PHASE3
NCT00520949 COMPLETED
Treatment of Helicobacter Pylori
Aga Khan University
 2006-10
NCT00003151 COMPLETED
Lymphoma
European Organisation for Research and Treatment of Cancer - EORTC
 1997-09 PHASE2

(data from https://clinicaltrials.gov, updated on 2024-11-07)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bismuth subcitrate potassium complexes with gastrointestinal proteins and precipitates within an acidic environment, directly inhibiting bacterial urease activity and disrupting cell wall structural integrity in *Helicobacter pylori*. This combined antimicrobial and mucosal-protective action prevents bacterial adherence and tissue damage, providing a clear mechanism for eradicating *Helicobacter pylori* infections and promoting the healing of gastric ulcers in clinical practice.

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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.