Optimization of Minocycline for Helicobacter Pylori Rescue Treatment

NCT06561711 | Completed Phase 4 DMC

• 1 other identifier: rjhy20240816
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 4

Brief Summary

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 (55.4%). Optimization of minocycline-based regimen to achieve high eradication rate with fewer adverse events is imperative. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy with different dosage of minocycline and metronidazole compared to classical bismuth quadruple therapy.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; rescue therapy; minocycline; tetracycline

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 7 days after completion of therapy

• Compliance rate

  Within 7 days after completion of therapy

Study Arms (4)

Minocycline group A

EXPERIMENTAL

Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg tid, Metronidazole 400mg tid

Drug: Vonoprazan; Drug: Bismuth Potassium Citrate; Drug: Minocycline,Metronidazole

Minocycline group B

EXPERIMENTAL

Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg qid

Drug: Vonoprazan; Drug: Bismuth Potassium Citrate; Drug: Minocycline,Metronidazole

Minocycline group C

EXPERIMENTAL

Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Minocycline 50mg bid, Metronidazole 400mg tid

Drug: Vonoprazan; Drug: Bismuth Potassium Citrate; Drug: Minocycline,Metronidazole

Tetracycline group

ACTIVE COMPARATOR

Vonoprazan 20mg bid, Bismuth Potassium Citrate 300mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid

Drug: Vonoprazan; Drug: Bismuth Potassium Citrate; Drug: Tetracycline,Metronidazole

Interventions

Vonoprazan DRUG

Potassium competitive acid blocker

Minocycline group A; Minocycline group B; Minocycline group C; Tetracycline group

Bismuth Potassium Citrate DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Minocycline group A; Minocycline group B; Minocycline group C; Tetracycline group

Tetracycline,Metronidazole DRUG

Antibiotics for H. pylori eradication

Tetracycline group

Minocycline,Metronidazole DRUG

Antibiotics for H. pylori eradication

Minocycline group A; Minocycline group B; Minocycline group C

Eligibility Criteria

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

You may qualify if:

• Ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection and with previous treatment experience

You may not qualify if:

• subjects naive to H. pylori treatment,
• under 18 or over 80 years old
• history of gastrectomy
• pregnant or lactating women
• Previous history of tuberculosis
• Allergy to any of the study drugs
• severe systemic diseases or malignancy
• administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (4)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

Songjiang Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Location

The Second Affiliated Hospital of Zhejiang University school of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

cyclopia sequence

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Tetracycline; Metronidazole; Minocycline

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• 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: August 16, 2024
• First Posted: August 20, 2024
• Study Start: August 21, 2024
• Primary Completion: February 21, 2026
• Study Completion: February 21, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (4)