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Helicobacter Pylori InfectionPhase 4NCT05049902

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication

A Phase 4 study testing Amoxicillin, Clarithromycin and Tetracycline 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 10-day or 14-day course of 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 65 years
Conditions the study is for
Helicobacter Pylori Infection
What is being tested?
Amoxicillin, Clarithromycin and Tetracycline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,300 participants
Where
6 sitesChina
Study dates
21 Sep 2021to 30 Jun 2023
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18-65.
  • Patients with H.pylori infection (Positive for any of the following: H.pylori culture, histopathology test, rapid urease test, 13C/14C-urea breath test, stool H.pylori antigen 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 3 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
Show all 9Show fewer
  • Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
  • Patients whose re-check 13C/14C-urea breath test is negative before the start of the test.
  • 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

  • Maternity and Child Care Health Center of Dezhou

    Dezhou, Shandong

  • Heze Municipal 3rd people's hospital

    Heze, Shandong

  • Qilu hosipital

    Jinan, Shandong, 257000

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • The People's Hospital of Jimo.Qingdao

    Qingdao

  • PKUCare Luzhong Hospital

    Zibo, Shandong

Other trials in China

About this study

Official title: Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Multicenter Randomized Clinical Trial of 10 and 14 Days

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of 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 10-day or 14-day course 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 10-day treatment group and a 14-day treatment group. The two groups of bismuth quadruple regimens are the same, as follows:

Option 1: Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate Option 2: Amoxicillin + Tetracycline + Bismuth + Vonoprazan fumarate Option 3: Amoxicillin + Metronidazole + Bismuth + Vonoprazan fumarate Three options are selected according to the hospital's situation.

Being tested
Amoxicillin, Clarithromycin, Tetracycline, Metronidazole, Bismuth Potassium Citrate
Keywords
Helicobacter pylori, Bismuth-containing quadruple regimen

What participants receive

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

  • AmoxicillinDrug

    Use according to the drug combination options selected by each center.

  • ClarithromycinDrug

    Use according to the drug combination options selected by each center.

  • TetracyclineDrug

    Use according to the drug combination options selected by each center.

  • MetronidazoleDrug

    Use according to the drug combination options selected by each center.

  • Bismuth Potassium CitrateDrug

    Use according to the drug combination options selected by each center.

  • Colloidal Bismuth PectinDrug

    Use according to the drug combination options selected by each center.

  • Vonoprazan fumarateDrug

    Use according to the drug combination options selected by each center.

Study groups in NCT05049902
Study groupRoleWhat they receive
10-day treatment groupExperimentalUse the following drug combination option for 10 days. Option 1: Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate Option 2: Amoxicillin + Tetracycline + Bismuth + Vonoprazan fumarate Option 3: Amoxicillin + Metronidazole + Bismuth + Vonoprazan fumarate Three options are selected according to the hospital's situation. The dosage of each drug is: Amoxicillin (Amoxicillin, United Laboratories Co., Ltd.) 1000mg bid Clarithromycin (Klacid, Abbott S.r.l) 500mg bid Tetracycline 500mg qid Metronidazole400mg qid Bismuth Potassium Citrate (Livzon Pharmaceutical Group Inc.) 220mg bid Colloidal Bismuth Pectin (North China Pharmaceutical Co., Ltd.) 200mg bid Vonoprazan fumarate (VOCINTI, Takeda Pharmaceutical Company Limited, Hikari Plant) 20mg bid
Receives: Drug: Amoxicillin; Drug: Clarithromycin; Drug: Tetracycline; Drug: Metronidazole; Drug: Bismuth Potassium Citrate; Drug: Colloidal Bismuth Pectin; Drug: Vonoprazan fumarate
14-day treatment groupActive comparatorUse the following drug combination option for 14 days. Option 1: Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate Option 2: Amoxicillin + Tetracycline + Bismuth + Vonoprazan fumarate Option 3: Amoxicillin + Metronidazole + Bismuth + Vonoprazan fumarate Three options are selected according to the hospital's situation. The dosage of each drug is: Amoxicillin (Amoxicillin, United Laboratories Co., Ltd.) 1000mg bid Clarithromycin (Klacid, Abbott S.r.l) 500mg bid Tetracycline 500mg qid Metronidazole400mg qid Bismuth Potassium Citrate (Livzon Pharmaceutical Group Inc.) 220mg bid Colloidal Bismuth Pectin (North China Pharmaceutical Co., Ltd.) 200mg bid Vonoprazan fumarate (VOCINTI, Takeda Pharmaceutical Company Limited, Hikari Plant) 20mg bid
Receives: Drug: Amoxicillin; Drug: Clarithromycin; Drug: Tetracycline; Drug: Metronidazole; Drug: Bismuth Potassium Citrate; Drug: Colloidal Bismuth Pectin; Drug: Vonoprazan fumarate

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 80% 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 posted20 Sep 2021
  2. Study start21 Sep 2021
  3. Primary completion30 May 2023
  4. Study completion30 Jun 2023

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
1,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05049902
Sponsor's protocol ID
2021-SDU-QILU-G001-2
Status last verified
Jul 2023
First submitted
5 Sep 2021
Last updated
19 Jul 2023
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

  • 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

  • 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

  • Liou JM, Malfertheiner P, Lee YC, Sheu BS, Sugano K, Cheng HC, Yeoh KG, Hsu PI, Goh KL, Mahachai V, Gotoda T, Chang WL, Chen MJ, Chiang TH, Chen CC, Wu CY, Leow AH, Wu JY, Wu DC, Hong TC, Lu H, Yamaoka Y, Megraud F, Chan FKL, Sung JJ, Lin JT, Graham DY, Wu MS, El-Omar EM; Asian Pacific Alliance on Helicobacter and Microbiota (APAHAM). Screening and eradication of Helicobacter pylori for gastric cancer prevention: the Taipei global consensus. Gut. 2020 Dec;69(12):2093-2112. doi: 10.1136/gutjnl-2020-322368. Epub 2020 Oct 1.

    PubMed 33004546

  • Dore MP, Farina V, Cuccu M, Mameli L, Massarelli G, Graham DY. Twice-a-day bismuth-containing quadruple therapy for Helicobacter pylori eradication: a randomized trial of 10 and 14 days. Helicobacter. 2011 Aug;16(4):295-300. doi: 10.1111/j.1523-5378.2011.00857.x.

    PubMed 21762269

  • Rowland M, Daly L, Vaughan M, Higgins A, Bourke B, Drumm B. Age-specific incidence of Helicobacter pylori. Gastroenterology. 2006 Jan;130(1):65-72; quiz 211. doi: 10.1053/j.gastro.2005.11.004.

    PubMed 16401469

  • O'Ryan ML, Rabello M, Cortes H, Lucero Y, Pena A, Torres JP. Dynamics of Helicobacter pylori detection in stools during the first 5 years of life in Chile, a rapidly developing country. Pediatr Infect Dis J. 2013 Feb;32(2):99-103. doi: 10.1097/INF.0b013e318278b929.

    PubMed 23076385

  • Qiao C, Li Y, Liu J, Ji C, Qu J, Hu J, Ji R, Wan M, Lin B, Lin M, Qi Q, Zuo X, Li Y. Clarithromycin versus furazolidone for naive Helicobacter pylori infected patients in a high clarithromycin resistance area. J Gastroenterol Hepatol. 2021 Sep;36(9):2383-2388. doi: 10.1111/jgh.15468. Epub 2021 Mar 10.

    PubMed 33691344

  • Ding YM, Duan M, Han ZX, Song XH, Zhang FL, Wang Z, Ning Z, Zeng SY, Kong QZ, Zhang WL, Liu J, Wan M, Lin MJ, Lin BS, Nan XP, Wang H, Li YY, Zuo XL, Li YQ. Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days. Dig Dis Sci. 2024 Jul;69(7):2540-2547. doi: 10.1007/s10620-024-08460-3. Epub 2024 May 3.

    PubMed 38700630

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Amoxicillin, Clarithromycin and Tetracycline 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 9 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 19 Jul 2023. 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 NCT05049902, 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 19 Jul 2023.

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