Minocycline for Helicobacter Pylori Rescue Treatment

NCT06332599 | Completed DMC

• 1 other identifier: rjhy20240001
• Study Type: observational
• Target: 823
• Locations: 1 country
• Sites: 1

Brief Summary

Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; rescue therapy; minocycline

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).

  Six weeks after completion of therapy

Secondary Outcomes (2)

• Rate of adverse effects

  Within six weeks after completion of therapy

• Compliance rate

  Within six weeks after completion of therapy

Study Arms (5)

BQT

Drug: BQT

PBM4M4

Drug: PBM4M4

PBM3M3

Drug: PBM3M3

PBM2M4

Drug: PBM2M4

PBM2M3

Drug: PBM2M3

Interventions

BQT DRUG

PPI（esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, tetracycline 500 mg four times a day, and metronidazole 400 mg four times a day

BQT

PBM4M4 DRUG

PPI（esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg four times a day, and metronidazole 400 mg four times a day

PBM4M4

PBM3M3 DRUG

PPI（esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg three times a day, and metronidazole 400 mg three times a day

PBM3M3

PBM2M4 DRUG

PPI（esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg twice daily, and metronidazole 400 mg four times a day

PBM2M4

PBM2M3 DRUG

PPI（esomeprazole or vonoprazan), bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg twice daily, and metronidazole 400 mg three times a day

PBM2M3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who failed at least two courses of H. pylori treatment containing clarithromycin, nitroimidazoles, fluoroquinolones, and/or amoxicillin, and received 14-day tetracycline/minocycline, metronidazole-containing bismuth quadruple therapy were identified. Patients with the following criteria were excluded: (1) naive to H. pylori treatment; (2) under 18 or over 80 years; (3) history of gastrectomy; (4) administration of antibiotics, bismuth, acid suppressants, or Chinese herb medicine in the preceding 12 weeks; (5) severe systemic diseases or malignancy.

You may qualify if:

• Confirmed H. pylori infection and with previous treatment failure

You may not qualify if:

• subjects naive to H. pylori treatment,
• history of gastrectomy
• pregnant or lactating women
• severe systemic diseases or malignancy
• administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 12 weeks

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, None Selected, 200127, China

Location

Related Publications (1)

• Huang Y, Qiu S, Guo Y, Chen J, Li M, Ding Z, Zhang W, Liang X, Lu H. Optimization of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Real-World Evidence Study. Helicobacter. 2024 Sep-Oct;29(5):e13138. doi: 10.1111/hel.13138.

  PMID: 39306798 DERIVED

MeSH Terms

Conditions

cyclopia sequence

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 27, 2024
• Study Start: March 1, 2021
• Primary Completion: March 30, 2024
• Study Completion: April 30, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)