UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056933 |
|---|---|
| Receipt number | R000065066 |
| Scientific Title | Efficacy and safety of precise dual therapy as first-line treatment for H. pylori infection in non-overweight patients |
| Date of disclosure of the study information | 2025/02/05 |
| Last modified on | 2025/02/04 22:48:22 |
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Basic information
Public title
Efficacy and safety of precise dual therapy as first-line treatment for H. pylori infection in non-overweight patients
Acronym
Precise dual therapy for H. pylori infection
Scientific Title
Efficacy and safety of precise dual therapy as first-line treatment for H. pylori infection in non-overweight patients
Scientific Title:Acronym
Precise dual therapy for H. pylori infection
Region
| Asia(except Japan) |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to evaluate the efficacy of body size guided dual therapy in treating Helicobacter pylori among non-overweight patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eradication rate of Helicobacter pylori
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Experimental group: Paitients accept body size guided dual therapy, which consists of amoxicillin with body size guided dosage (BMI<18.5: 2g/d; BMI>=18.5 and BMI<20.33: 2.25g/d; BMI>=20.33 and BMI<22.16: 2.5g/d; BMI>=22.16 and BMI<=24: 2.75g/d) plus vonoprazon 40mg/d
Interventions/Control_2
Control group: Paitients accept high dose dual therapy, which consisted of amoxicillin (3g/d) plus vonoprazon (40mg/d).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) positive for either the 13C-urea breath test (13C-UBT) and/or positive pathological section staining of H. pylori within the past 3 months, and the diagnostic process meets the criteria of the Sixth National Consensus on the Management of Helicobacter pylori Infection; (2) no history of treatment with H. pylori eradication, (3) aged 18-70 years old, (4) BMI<=24kg/m2, and (5) fully informed and agreed to participate in this study.
Key exclusion criteria
(1) received medications that might affect the study results up to 4 weeks prior to enrollment, including H2 receptor antagonists, proton pump inhibitors, competitive potassium pump blockers, bismuth agents, or antibiotics (2) patients with any current complications with additional medication required, such as malignant tumors, digestive ulcers, gastrointestinal bleeding, reflux esophagitis; (3) patients with a history upper gastrointestinal surgery; (4) patients with systemic diseases, including severe liver or kidney damage; (5) patients allergic to the medicines used in this study; (6) women who were pregnant or lactating; (7) patients with long-term use of glucocorticoids or nonsteroidal anti-inflammatory medicines; and (8) patients with mental abnormalities who had difficulties cooperating with the investigator.
Target sample size
94
Research contact person
Name of lead principal investigator
| 1st name | Xiao-Bei |
| Middle name | |
| Last name | Si |
Organization
Beijing Jishuitan Hospital, Capital Medical University
Division name
Departement of Gastroenterology
Zip code
100096
Address
No. 96, Huinan North Road, Changping District, Beijing
TEL
+86-10-58398289
sixiaobei2008@126.com
Public contact
Name of contact person
| 1st name | Xiao-Bei |
| Middle name | |
| Last name | Si |
Organization
Beijing Jishuitan Hospital, Capital Medical University
Division name
Departement of Gastroenterology
Zip code
100096
Address
No. 96, Huinan North Road, Changping District, Beijing
TEL
+86-10-58398289
Homepage URL
sixiaobei2008@126.com
Sponsor or person
Institute
Beijing Jishuitan Hospital Nova Program
Institute
Department
Personal name
Funding Source
Organization
Beijing Jishuitan Hospital, Capital Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Beijing Jishuitan Hospital, Capital Medical University
Address
No. 96, Huinan North Road, Changping District, Beijing
Tel
+86-10-58516688
cmuwxl@126.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065066
