NCT05997433

Brief Summary

Helicobacter pylori (H. pylori) infection is a common global infectious disease of the gastrointestinal tract. Helicobacter pylori eradication can effectively prevent the development of gastric cancer.The researchers collect H.pylori-positive patients who need native therapy. The subjects were randomized to receive7 days and 14 days 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 and patient compliance of each group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

September 2, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

August 11, 2023

Last Update Submit

January 9, 2024

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (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.

    Immediately after follow-up check

Secondary Outcomes (2)

  • Rate of adverse reactions

    Immediately after follow-up check

  • Patient compliance

    Immediately after follow-up check

Study Arms (2)

7 days

EXPERIMENTAL

Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid

Procedure: 7days bismuth quadruple

14 days

ACTIVE COMPARATOR

Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid

Procedure: 14 days bismuth quadruple

Interventions

7days bismuth quadruplePROCEDURE

Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid\*7days

Also known as: Amoxicillin, Tetracycline, Bismuth, Tegoprazan
7 days
14 days bismuth quadruplePROCEDURE

Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid\*14days

Also known as: Amoxicillin, Tetracycline, Bismuth, Tegoprazan
14 days

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-70.
  • Without active hepatitis.
  • Helicobacter pylori infection (either positive for rapid urease test, C13/C14 urea breath test).
  • Patients who have not previously received helicobacter pylori eradication therapy.

You may not qualify if:

  • Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (9)

  • 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.

    PMID: 28456631RESULT

  • Malfertheiner P, Megraud F, O'Morain C, Bazzoli F, El-Omar E, Graham D, Hunt R, Rokkas T, Vakil N, Kuipers EJ. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut. 2007 Jun;56(6):772-81. doi: 10.1136/gut.2006.101634. Epub 2006 Dec 14.

    PMID: 17170018RESULT

  • Cho JH, Jin SY. Current guidelines for Helicobacter pylori treatment in East Asia 2022: Differences among China, Japan, and South Korea. World J Clin Cases. 2022 Jul 6;10(19):6349-6359. doi: 10.12998/wjcc.v10.i19.6349.

    PMID: 35979311RESULT

  • Zhou XZ, Lyu NH, Zhu HY, Cai QC, Kong XY, Xie P, Zhou LY, Ding SZ, Li ZS, Du YQ; 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.. Large-scale, national, family-based epidemiological study on Helicobacter pylori infection in China: the time to change practice for related disease prevention. Gut. 2023 May;72(5):855-869. doi: 10.1136/gutjnl-2022-328965. Epub 2023 Jan 23.

    PMID: 36690433RESULT

  • 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.

    PMID: 34836916RESULT

  • 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.

    PMID: 33004546RESULT

  • Moon SG, Lim CH, Kang HJ, Choi A, Kim S, Oh JH. Seven Days of Bismuth-Based Quadruple Therapy Is as Effective for the First-Line Treatment of Clarithromycin-Resistant Confirmed Helicobacter pylori Infection as 14 Days of Bismuth-Based Quadruple Therapy. J Clin Med. 2022 Jul 30;11(15):4440. doi: 10.3390/jcm11154440.

    PMID: 35956057RESULT

  • 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.

    PMID: 33691344RESULT

  • Nan XP, Zhao HY, Guo LN, Zheng RQ, Wang XL, Wang YF, Su YH, Geng WR, Liu XL, Xu HM, Zhou KL, Guo YT, Cao JH, Han ZX, Kong QZ, Zuo XL, Li YQ, Li YY. Seven-Day Versus 14-Day Tegoprazan and Tetracycline-Containing Quadruple Therapy for First-Line Eradication of Helicobacter pylori Infection: A Randomized, Open-Label, Noninferiority Trial. Helicobacter. 2025 Mar-Apr;30(2):e70036. doi: 10.1111/hel.70036.

    PMID: 40272011DERIVED

MeSH Terms

Interventions

AmoxicillinTetracyclineBismuthtegoprazan

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsElements, RadioactiveElementsInorganic ChemicalsMetals, HeavyRadioisotopesIsotopesMetals

Study Officials

  • Yanqing Li, Ph.D

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqing Li, Ph.D

CONTACT

+8653188369277liyanqing@sdu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 11, 2023

First Posted

August 18, 2023

Study Start

September 2, 2023

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

January 11, 2024

Record last verified: 2024-01

Locations

CN(1)