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NCT06603688
Study on the Efficacy and Safety of Berberine, Minocycline, Esomeprazole, and Colloidal Bismuth Quadruple Therapy in the Initial Treatment of Helicobacter Pylori.
Phase 4 trial testing esomeprazole in Helicobacter Pylori Infection in 548 participants. Status unknown.
1 November 2024
Quick facts
| Lead sponsor | Xijing Hospital of Digestive Diseases |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 548 |
| Start date | 20 November 2023 |
| Primary completion | 1 November 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- esomeprazole (esomeprazole) — full drug profile →
- Bismuth
- Amoxicillin (amoxicillin) — full drug profile →
- clarithromycin (clarithromycin) — full drug profile →
- Berberine — full drug profile →
- Minocycline (MINOCYCLINE) — full drug profile →
Conditions studied
- Helicobacter Pylori Infection — all drugs for Helicobacter Pylori Infection →
- Chronic Gastritis — all drugs for Chronic Gastritis →
Sponsor
Xijing Hospital of Digestive Diseases
Who can join
Adults 18 to 70, any sex, with Helicobacter Pylori Infection or Chronic Gastritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori. Assuming that the quadruple therapy of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin. Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments. During the 6-week follow-up, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be performed to confirm eradication. The aim of this study is to evaluate the efficacy and safety of a quadruple therapy consisting of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate for the first phase eradication of Helicobacter pylori. Assuming that the quadruple therapy of berberine hydrochloride, minocycline, esomeprazole, and colloidal bismuth tartrate is no less effective than the bismuth containing quadruple therapy of amoxicillin and clarithromycin. Patients diagnosed with Helicobacter pylori infection will be randomly assigned to one of the aforementioned treatments. During the 6-week follow-up, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be performed to confirm eradication.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Plant-derived extracts or compounds for Helicobacter-associated gastritis: a systematic review of their anti-Helicobacter activity and anti-inflammatory effect in animal experiments.
Chen D, Wang W, Chen X, Liang N, et al · · 2025 · cited 2× · PMID 40264171 · DOI 10.1186/s13020-025-01093-2
Verify or expand the search:
- PubMed search for NCT06603688
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Xijing Hospital of Digestive Diseases trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06603688 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xijing Hospital of Digestive Diseases
- Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06603688.
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