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Helicobacter Pylori InfectionNCT05620589

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

An observational study of Helicobacter Pylori Infection, run by Shandong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Helicobacter Pylori Infection
What is being tested?
Amoxicillin + Tetracycline + Bismuth + Esomeprazole, Amoxicillin + Tetracycline + Bismuth + Vonoprazan and Amoxicillin + Tetracycline + Bismuth + Tegoprazan
How many people
626 participants
Where
1 siteChina
Study dates
11 Nov 2022to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Qilu Hospital, Shandong University

    Jinan, Shandong, 250012

Other trials in China

About this study

Official title: The Effect of Different Time Intervals on Rescue Treatment of Helicobacter Pylori Infection: a Prospective, Multicenter Observational Study

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.

Being tested
Amoxicillin + Tetracycline + Bismuth + Esomeprazole, Amoxicillin + Tetracycline + Bismuth + Vonoprazan, Amoxicillin + Tetracycline + Bismuth + Tegoprazan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amoxicillin + Tetracycline + Bismuth + EsomeprazoleDrug

    Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 40mg bid or Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 40mg bid

  • Amoxicillin + Tetracycline + Bismuth + VonoprazanDrug

    Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth +Vonoprazan 20mg bid or Amoxicillin1000mg bid+ Tetracycline 500mg tid+ Bismuth + Vonoprazan 20mg bid

  • Amoxicillin + Tetracycline + Bismuth + TegoprazanDrug

    Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid or Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Tegopraza 50mg bid

Study groups in NCT05620589
Study groupRoleWhat they receive
Amoxicillin + Tetracycline + Bismuth + EsomeprazoleAmoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 40mg bid or Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 40mg bid
Receives: Drug: Amoxicillin + Tetracycline + Bismuth + Esomeprazole
Amoxicillin + Tetracycline + Bismuth + VonoprazanAmoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth +Vonoprazan 20mg bid or Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Vonoprazan 20mg bid
Receives: Drug: Amoxicillin + Tetracycline + Bismuth + Vonoprazan
Amoxicillin + Tetracycline 5+ Bismuth + TegoprazanAmoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid or Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Tegoprazan 50mg bid
Receives: Drug: Amoxicillin + Tetracycline + Bismuth + Tegoprazan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: immediately after the procedure

Secondary outcomes (2)

  1. Type、Rate and severtiry of adverse reactions

    Type、Rate and severtiry of adverse reactions

    Measured: 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.

    Measured: Immediately after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2022
  2. Study start11 Nov 2022 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
626 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05620589
Sponsor's protocol ID
2022-SDU-QILU-G006
Status last verified
Nov 2022
First submitted
10 Nov 2022
Last updated
17 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Helicobacter Pylori Infection, run by Shandong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eradication rate at different time intervals (time frame: immediately after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05620589, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.

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