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Status unknownNCT05620602Updated Nov 17, 2022

The Effect of Time Intervals for Rescue Treatment on Eradication Effect of Helicobacter Pylori Infection

An observational study in Helicobacter Pylori Infection, sponsored by Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-11-17.

Sponsored by Shandong University · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
628
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. After rescue therapy, evaluating the effect of retreatment interval on eradication effect of Helicobacter pylori infection.

Read the detailed description

The researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. Record the interval between the last eradication therapy and this time,6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculating the eradication rates, adverse reaction rates, patient compliance of each group. Evaluating the effect of retreatment interval on eradication effect of Helicobacter pylori infection.

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Conditions studied

  • Helicobacter Pylori Infection
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In context

Lead sponsor

Shandong University is the lead sponsor of 291 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The patients in Shandong province,aged between 18 and 70 years old, with positive H. pylori infection that was eradicated by previous therapies but failed are included.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18-70.
  • Patients with H.pylori infection (Positive for any of the following: 13C/14C-urea breath test, histopathology test, rapid urease test, stool H.pylori antigen test).
  • Patients who have previously received helicobacter pylori eradication therapy and failed.

Exclusion criteria

Exclusion Criteria:

  • Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
  • Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
  • Patients with active gastrointestinal bleeding.
  • Patients with a history of upper gastrointestinal surgery.
  • Patients allergic to treatment drugs.
  • Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
  • Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
  • Patients who are unwilling or incapable to provide informed consents.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
628 participants (estimated)
Patient registry
No

Groups and cohorts

  • Remedial treatment within 3 months

    Other: Remedial treatment within 3 months

  • Remedial treatment within 3 to 6 months

    Other: Remedial treatment within 3 to 6 months

  • Remedial treatment within 6 to 12 months

    Other: Remedial treatment within 6 to 12 months

  • Remedial treatment after 12 months

    Other: Remedial treatment after 12 months

Interventions

  • OtherRemedial treatment within 3 months

    The interval between the time of this treatment and the last day of the last therapy is within 3 months.Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.

  • OtherRemedial treatment within 3 to 6 months

    The interval between the time of this treatment and the last day of the last therapy is 3-6 months. Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.

  • OtherRemedial treatment within 6 to 12 months

    The interval between the time of this treatment and the last day of the last therapy is 6-12 months Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.

  • OtherRemedial treatment after 12 months

    The interval between the time of this treatment and the last day of the last therapy is more than 12 months Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.

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What researchers measure

Primary outcomes

  1. Eradication rate at different time intervals

    Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

    Time frame: immediately after the procedure

Secondary outcomes

  1. Type、Rate and severtiry of adverse reactions

    Type、Rate and severtiry of adverse reactions

    Time frame: Immediately after the procedure

  2. Patient compliance

    Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.

    Time frame: Immediately after the procedure

07

Study locations

1 site
  • Qilu Hospital, Shandong University
    Jinan, Shandong 250012, China
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References and documents

Publications

  • Du LJ, Chen BR, Kim JJ, Kim S, Shen JH, Dai N. Helicobacter pylori eradication therapy for functional dyspepsia: Systematic review and meta-analysis. World J Gastroenterol. 2016 Mar 28;22(12):3486-95. doi: 10.3748/wjg.v22.i12.3486. PubMed 27022230 ↗
  • Alba C, Blanco A, Alarcon T. Antibiotic resistance in Helicobacter pylori. Curr Opin Infect Dis. 2017 Oct;30(5):489-497. doi: 10.1097/QCO.0000000000000396. PubMed 28704226 ↗
  • Donelli G, Matarrese P, Fiorentini C, Dainelli B, Taraborelli T, Di Campli E, Di Bartolomeo S, Cellini L. The effect of oxygen on the growth and cell morphology of Helicobacter pylori. FEMS Microbiol Lett. 1998 Nov 1;168(1):9-15. doi: 10.1111/j.1574-6968.1998.tb13248.x. PubMed 9812358 ↗
  • Catrenich CE, Makin KM. Characterization of the morphologic conversion of Helicobacter pylori from bacillary to coccoid forms. Scand J Gastroenterol Suppl. 1991;181:58-64. PubMed 1866596 ↗
  • Benaissa M, Babin P, Quellard N, Pezennec L, Cenatiempo Y, Fauchere JL. Changes in Helicobacter pylori ultrastructure and antigens during conversion from the bacillary to the coccoid form. Infect Immun. 1996 Jun;64(6):2331-5. doi: 10.1128/iai.64.6.2331-2335.1996. PubMed 8675345 ↗
  • Xu HS, Roberts N, Singleton FL, Attwell RW, Grimes DJ, Colwell RR. Survival and viability of nonculturableEscherichia coli andVibrio cholerae in the estuarine and marine environment. Microb Ecol. 1982 Dec;8(4):313-23. doi: 10.1007/BF02010671. PubMed 24226049 ↗
  • Su X, Chen X, Hu J, Shen C, Ding L. Exploring the potential environmental functions of viable but non-culturable bacteria. World J Microbiol Biotechnol. 2013 Dec;29(12):2213-8. doi: 10.1007/s11274-013-1390-5. Epub 2013 Jun 4. PubMed 23733177 ↗
  • Lleo MM, Bonato B, Tafi MC, Signoretto C, Boaretti M, Canepari P. Resuscitation rate in different enterococcal species in the viable but non-culturable state. J Appl Microbiol. 2001 Dec;91(6):1095-102. doi: 10.1046/j.1365-2672.2001.01476.x. PubMed 11851818 ↗
  • Senoh M, Ghosh-Banerjee J, Ramamurthy T, Colwell RR, Miyoshi S, Nair GB, Takeda Y. Conversion of viable but nonculturable enteric bacteria to culturable by co-culture with eukaryotic cells. Microbiol Immunol. 2012 May;56(5):342-5. doi: 10.1111/j.1348-0421.2012.00440.x. PubMed 22537150 ↗
  • Ozbek A, Ozbek E, Dursun H, Kalkan Y, Demirci T. Can Helicobacter pylori invade human gastric mucosa?: an in vivo study using electron microscopy, immunohistochemical methods, and real-time polymerase chain reaction. J Clin Gastroenterol. 2010 Jul;44(6):416-22. doi: 10.1097/MCG.0b013e3181c21c69. PubMed 19904218 ↗
  • Liu WZ, Xie Y, Lu H, Cheng H, Zeng ZR, Zhou LY, Chen Y, Wang JB, Du YQ, Lu NH; Chinese Society of Gastroenterology, Chinese Study Group on Helicobacter pylori and Peptic Ulcer. Fifth Chinese National Consensus Report on the management of Helicobacter pylori infection. Helicobacter. 2018 Apr;23(2):e12475. doi: 10.1111/hel.12475. Epub 2018 Mar 7. PubMed 29512258 ↗
  • Hwang JJ, Lee DH, Lee AR, Yoon H, Shin CM, Park YS, Kim N. Fourteen- vs seven-day bismuth-based quadruple therapy for second-line Helicobacter pylori eradication. World J Gastroenterol. 2015 Jul 14;21(26):8132-9. doi: 10.3748/wjg.v21.i26.8132. PubMed 26185386 ↗
  • Nyssen OP, Perez-Aisa A, Rodrigo L, Castro M, Mata Romero P, Ortuno J, Barrio J, Huguet JM, Modollel I, Alcaide N, Lucendo A, Calvet X, Perona M, Gomez B, Gomez Rodriguez BJ, Varela P, Jimenez-Moreno M, Dominguez-Cajal M, Pozzati L, Burgos D, Bujanda L, Hinojosa J, Molina-Infante J, Di Maira T, Ferrer L, Fernandez-Salazar L, Figuerola A, Tito L, de la Coba C, Gomez-Camarero J, Fernandez N, Caldas M, Garre A, Resina E, Puig I, O'Morain C, Megraud F, Gisbert JP. Bismuth quadruple regimen with tetracycline or doxycycline versus three-in-one single capsule as third-line rescue therapy for Helicobacter pylori infection: Spanish data of the European Helicobacter pylori Registry (Hp-EuReg). Helicobacter. 2020 Oct;25(5):e12722. doi: 10.1111/hel.12722. Epub 2020 Jul 13. PubMed 32656898 ↗
  • Fiorini G, Saracino IM, Zullo A, Gatta L, Pavoni M, Vaira D. Rescue therapy with bismuth quadruple regimen in patients with Helicobacter pylori -resistant strains. Helicobacter. 2017 Dec;22(6). doi: 10.1111/hel.12448. Epub 2017 Nov 1. PubMed 29094477 ↗
  • Lee JW, Kim N, Nam RH, Lee SM, Soo In C, Kim JM, Lee DH. Risk factors of rescue bismuth quadruple therapy failure for Helicobacter pylori eradication. J Gastroenterol Hepatol. 2019 Apr;34(4):666-672. doi: 10.1111/jgh.14625. Epub 2019 Feb 25. PubMed 30726563 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05620602
Collaborators
Peking University Care Luzhong Hospital, Yuncheng Traditional Chinese Medicine Hospital, Taierzhuang District People's Hospital, Zhengzhou Central Hospital, Zibo Central Hospital
Responsible party
Xiuli Zuo (director of Qilu Hospital gastroenterology department, Shandong University) — Principal investigator
First posted
Nov 17, 2022
Start date
Nov 11, 2022 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Nov 17, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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