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Helicobacter Pylori InfectionPhase 4NCT05431075

Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment of Different Tetracycline Doses

A Phase 4 study testing Amoxicillin, Tetracycline tid and Tetracycline qid in people with Helicobacter Pylori Infection, run by Shandong University at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. 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 tid and Tetracycline qid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
6 sitesChina
Study dates
1 Jul 2022to 1 Feb 2024
Phase
Phase 4
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

Who may be able to join

  • Patients aged 18-70.
  • Patients with H.pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).
  • Patients who have never received H. pylori eradication treatment.

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

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Qilu hosipital

    Jinan, Shandong, 257000

  • Taierzhuang District People's Hospital

    Taierzhuang, Shandong

  • Yuncheng Hospital of Traditional Chinese Medicine

    Yuncheng, Shandong

  • Zhengzhou Central Hospital

    Zhengzhou, Henan

  • PKUCare Luzhong Hospital

    Zibo, Shandong

  • Zibo Central Hospital

    Zibo, Shandong

Other trials in China

About this study

Official title: Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment: A Multicenter Randomized Clinical Trial of Different Tetracycline Doses and Frequencies.

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

Read the detailed description

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a dose and frequency of tetracycline 500mg tid or qid of bismuth-containing quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results.

After all subjects were tested, the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group were calculated.

According to the course of treatment, it is randomized into a tid treatment group and a qid treatment group. The two groups of bismuth quadruple regimens are the same, as follows:

Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 20mg bid Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 20mg bid

Being tested
Amoxicillin, Tetracycline tid, Tetracycline qid, Bismuth Potassium Citrate, Colloidal Bismuth Pectin
Keywords
Helicobacter pylori, tetracycline, Bismuth-containing quadruple regimen

What participants receive

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

  • AmoxicillinDrug

    Included in quadruple eradication medication.

  • Tetracycline tidDrug

    Included in quadruple eradication medication.

  • Tetracycline qidDrug

    Included in quadruple eradication medication.

  • Bismuth Potassium CitrateDrug

    Included in quadruple eradication medication.

  • Colloidal Bismuth PectinDrug

    Included in quadruple eradication medication.

  • Esomeprazole 20mgDrug

    Included in quadruple eradication medication.

Study groups in NCT05431075
Study groupRoleWhat they receive
Tid groupExperimentalTid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 20mg bid
Receives: Drug: Amoxicillin; Drug: Tetracycline tid; Drug: Bismuth Potassium Citrate; Drug: Colloidal Bismuth Pectin; Drug: Esomeprazole 20mg
Qid groupActive comparatorQid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 20mg bid
Receives: Drug: Amoxicillin; Drug: Tetracycline qid; Drug: Bismuth Potassium Citrate; Drug: Colloidal Bismuth Pectin; Drug: Esomeprazole 20mg

What is being measured

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

  1. Eradication rate

    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 follow-up check.

Secondary outcomes (3)

  1. Rate of adverse reactions

    Rate of adverse reactions

    Measured: Immediately after follow-up check.

  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 follow-up check.

  3. Cost-effectiveness index

    Ratio of costs to effectiveness

    Measured: Immediately after follow-up check.

Timeline

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

  1. First posted24 Jun 2022
  2. Study start1 Jul 2022
  3. Primary completion1 Feb 2024
  4. Study completion1 Feb 2024

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This trial is a multi-center, open-label, non-inferiority, randomized controlled trial.
Masking
None (open label)
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05431075
Sponsor's protocol ID
2022-SDU-QILU-G004
Status last verified
Mar 2024
First submitted
18 Jun 2022
Last updated
27 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27.

    PubMed 28456631

  • Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.

    PubMed 27707777

  • Ding SZ, Du YQ, Lu H, Wang WH, Cheng H, Chen SY, Chen MH, Chen WC, Chen Y, Fang JY, Gao HJ, Guo MZ, Han Y, Hou XH, Hu FL, Jiang B, Jiang HX, Lan CH, Li JN, Li Y, Li YQ, Liu J, Li YM, Lyu B, Lu YY, Miao YL, Nie YZ, Qian JM, Sheng JQ, Tang CW, Wang F, Wang HH, Wang JB, Wang JT, Wang JP, Wang XH, Wu KC, Xia XZ, Xie WF, Xie Y, Xu JM, Yang CQ, Yang GB, Yuan Y, Zeng ZR, Zhang BY, Zhang GY, Zhang GX, Zhang JZ, Zhang ZY, Zheng PY, Zhu Y, Zuo XL, Zhou LY, Lyu NH, Yang YS, Li ZS; National Clinical Research Center for Digestive Diseases (Shanghai), Gastrointestinal Early Cancer Prevention & Treatment Alliance of China (GECA), Helicobacter pylori Study Group of Chinese Society of Gastroenterology, and Chinese Alliance for Helicobacter pylori Study. Chinese Consensus Report on Family-Based Helicobacter pylori Infection Control and Management (2021 Edition). Gut. 2022 Feb;71(2):238-253. doi: 10.1136/gutjnl-2021-325630. Epub 2021 Nov 26.

    PubMed 34836916

  • Lv ZF, Wang FC, Zheng HL, Wang B, Xie Y, Zhou XJ, Lv NH. Meta-analysis: is combination of tetracycline and amoxicillin suitable for Helicobacter pylori infection? World J Gastroenterol. 2015 Feb 28;21(8):2522-33. doi: 10.3748/wjg.v21.i8.2522.

    PubMed 25741163

  • Marko D, Calvet X, Ducons J, Guardiola J, Tito L, Bory F; GRESCA (Group for Eradication Studies from Catalonia and Aragon). Comparison of two management strategies for Helicobacter pylori treatment: clinical study and cost-effectiveness analysis. Helicobacter. 2005 Feb;10(1):22-32. doi: 10.1111/j.1523-5378.2005.00288.x.

    PubMed 15691312

  • Calvet X, Montserrat A, Guell M, Vergara M, Gene E. Ranitidine-bismuth citrate, tetracycline and metronidazole followed by triple therapy as alternative strategy for Helicobacter pylori treatment: a pilot study. Eur J Gastroenterol Hepatol. 2004 Oct;16(10):987-90. doi: 10.1097/00042737-200410000-00006.

    PubMed 15371921

  • Xie Y, Zhu Z, Wang J, Zhang L, Zhang Z, Lu H, Zeng Z, Chen S, Liu D, Lv N; the Chinese Study Group on Helicobacter pylori, Chinese Society of Gastroenterology. Ten-Day Quadruple Therapy Comprising Low-Dose Rabeprazole, Bismuth, Amoxicillin, and Tetracycline Is an Effective and Safe First-Line Treatment for Helicobacter pylori Infection in a Population with High Antibiotic Resistance: a Prospective, Multicenter, Randomized, Parallel-Controlled Clinical Trial in China. Antimicrob Agents Chemother. 2018 Aug 27;62(9):e00432-18. doi: 10.1128/AAC.00432-18. Print 2018 Sep.

    PubMed 29914954

  • Zhang J, Han C, Lu WQ, Wang N, Wu SR, Wang YX, Ma JP, Wang JH, Hao C, Yuan DH, Liu N, Shi YQ. A randomized, multicenter and noninferiority study of amoxicillin plus berberine vs tetracycline plus furazolidone in quadruple therapy for Helicobacter pylori rescue treatment. J Dig Dis. 2020 May;21(5):256-263. doi: 10.1111/1751-2980.12870. Epub 2020 Jun 9.

    PubMed 32348007

  • Ding YM, Zhang QM, Li RL, Han ZX, Zhao Q, Xu LD, Wang KY, Nan XP, Duan M, Zeng SY, Kong QZ, Wang H, Wu XQ, Zhang N, Li YQ, Zuo XL, Li YY. Tetracycline Three Times Daily Versus Four Times Daily in Bismuth-Containing Quadruple Therapy as the First-Line Treatment of Helicobacter pylori Infection: A Multicenter, Noninferiority, Randomized Controlled Trial. Helicobacter. 2024 Jul-Aug;29(4):e13121. doi: 10.1111/hel.13121.

    PubMed 39097924

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Amoxicillin, Tetracycline tid and Tetracycline qid in people with Helicobacter Pylori Infection, run by Shandong University at 6 sites 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (time frame: Immediately after follow-up check.). 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 NCT05431075, which also lists 9 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 27 Mar 2024.

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