Helicobacter InfectionsNCT03365609
A Comparison of Four Different Treatment Regimens of Helicobacter Pylori in Chinese Children
A study testing triple therapy, sequential therapy and bismuth quadruple therapy in people with Helicobacter Infections, run by Ying HUANG at 1 site in China.
Trial summary
With the resistance of Helicobacter pylori increasing, low and unsatisfactory eradication rate (64%) have been observed with standard triple therapy in European children. Which regimen is appropriate for Chinese children? There is no large scale, multi center studies in China about treatment, CYP2C19 gene… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Helicobacter Infections
- What is being tested?
- triple therapy, sequential therapy and bismuth quadruple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2017to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children 6-18 years of age who were referred for upper endoscopy and confirmed to have Hp infection
Who cannot join
- patients were excluded if they had taken proton pump inhibitors, H2-receptor antagonists or antibiotics in the 4 weeks prior to the study. Patients with known antibiotic allergy,hepatic impairment or kidney failure were also excluded. Patients who received Hp therapy before were also excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's hospital of Fudan university
Shanghai, Shanghai Municipality, 201102
Ying Huang, MD and PhD, 13816882247, yhuang815@163.com
Ying Zhou
About this study
Official title: A Comparison of Four Different Treatment Regimens as the First-line Treatment of Helicobacter Pylori in Chinese Children and Investigation of Resistance and Impact factors-a Multicenter Study
With the resistance of Helicobacter pylori increasing, low and unsatisfactory eradication rate (64%) have been observed with standard triple therapy in European children. Which regimen is appropriate for Chinese children? There is no large scale, multi center studies in China about treatment, CYP2C19 gene polymorphism, resistance rate and resistance genotype. Investigators want to perform a research to compare four different treatment regimens（triple therapy, sequential therapy, bismuth quadruple therapy and concomitant therapy）as the first-line treatment of Helicobacter pylori in Chinese children and investigation of resistance, impact factors and changes of microbiota after the therapy. The results of the study will provide theoretical basis to make the new guideline of diagnosis and therapy of Helicobacter pylori in Chinese children. It advance instruct and norm the clinical practice for Chinese pediatrician to increase the cure rate of Helicobacter pylori and decrease the resistance.
Read the detailed description
Eligible children were randomly divided into four groups: standard triple therapy, sequential therapy, bismuth quadruple therapy and concomitant therapy. The course of treatment is 14 days. The primary outcome measure was the Hp eradication rate at 4-6 weeks after completion of treatment which was confirmed by a negative of 13 UBT. Secondary outcome measures included side effects, impact factor and changes of microbiome after the therapy.
- Conditions
- Helicobacter Infections
- Being tested
- triple therapy, sequential therapy, bismuth quadruple therapy, concomitant therapy
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triple therapyDrug
Omeprazole+Amoxicillin+Clarithromycin
sequential therapyDrug
the first 7 days : Omeprazole+Amoxicillin, the last 7 days: Omeprazole+Clarithromycin+Metronidazole
bismuth quadruple therapyDrug
Omeprazole+Amoxicillin+Metronidazole+Colloidal Bismuth Subcitrate
concomitant therapyDrug
Omeprazole+Amoxicillin+Clarithromycin+Metronidazole
| Study group | Role | What they receive |
|---|---|---|
| T-group | Experimental | T-group(triple therapy) Receives: Drug: triple therapy |
| S-group | Experimental | S-group( sequential therapy) Receives: Drug: sequential therapy |
| B-group | Experimental | B-group( bismuth quadruple therapy ) Receives: Drug: bismuth quadruple therapy |
| C-group | Experimental | C-group( concomitant therapy) Receives: Drug: concomitant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
13C-UBT
13C-UBT was used to determine whether Hp treatments was successful
Measured: 13C-UBT was assessed at 4-6 weeks after completion of therapy
Secondary outcomes (8)
side effects
such as diarrea,rash,dark stool
Measured: assess at 2,4-6weeks after completion of the therapy
changes of Shannon diversity indices for gut microbiome
changes of the Shannon diversity indices
Measured: assess at 0,2,4-6weeks after completion of the therapy
changes of OTU for gut microbiome
changes of OTU
Measured: assess at 0,2,4-6weeks after completion of the therapy
changes of abundances for gut microbiome
changes of abundances of the bacteria
Measured: assess at ,2,4-6weeks after completion of the therapy
CYP2C19 gene that impact the metabolism of PPI
CYP2C19 gene polymorphism
Measured: detect the gene before the therapy
virulence gene-cagA
cagA
Measured: detect the gene before the therapy
virulence gene-vacA
vacA
Measured: detect the gene before the therapy
patient compliance
good compliance is defined as taking more than 80% drugs
Measured: assess compliance 2 weeks after the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start20 Sep 2017
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ying HUANG
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Women and Children's Medical Center, The Children's Hospital of Zhejiang University School of Medicine, Beijing Children's Hospital, Tang-Du Hospital
- Responsible party
- Sponsor-investigator, Ying HUANG, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365609
- Sponsor's protocol ID
- HPT2017
- Status last verified
- Feb 2025
- First submitted
- 20 Nov 2017
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones NL, Koletzko S, Goodman K, Bontems P, Cadranel S, Casswall T, Czinn S, Gold BD, Guarner J, Elitsur Y, Homan M, Kalach N, Kori M, Madrazo A, Megraud F, Papadopoulou A, Rowland M; ESPGHAN, NASPGHAN. Joint ESPGHAN/NASPGHAN Guidelines for the Management of Helicobacter pylori in Children and Adolescents (Update 2016). J Pediatr Gastroenterol Nutr. 2017 Jun;64(6):991-1003. doi: 10.1097/MPG.0000000000001594.
PubMed 28541262
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Four Different Treatment Regimens as the First-line Treatment of Helicobacter Pylori in Chinese Children and Investigation of Resistance and Impact factors-a Multicenter Study
- ClinicalTrials.gov ID
- NCT03365609
- Acronym / sponsor ID
- HPT2017
- Conditions
- Helicobacter Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- Ying HUANGUniversity, hospital or other
- Collaborators
- Guangzhou Women and Children's Medical Center, The Children's Hospital of Zhejiang University School of Medicine, Beijing Children's Hospital, Tang-Du Hospital
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the resistance of Helicobacter pylori increasing, low and unsatisfactory eradication rate (64%) have been observed with standard triple therapy in European children. Which regimen is appropriate for Chinese children? There is no large scale, multi center studies in China about treatment, CYP2C19 gene polymorphism, resistance rate and resistance genotype. Investigators want to perform a research to compare four different treatment regimens（triple therapy, sequential therapy, bismuth quadruple therapy and concomitant therapy）as the first-line treatment of Helicobacter pylori in Chinese children and investigation of resistance, impact factors and changes of microbiota after the therapy. The results of the study will provide theoretical basis to make the new guideline of diagnosis and therapy of Helicobacter pylori in Chinese children. It advance instruct and norm the clinical practice for Chinese pediatrician to increase the cure rate of Helicobacter pylori and decrease the resistance.
Detailed description
Eligible children were randomly divided into four groups: standard triple therapy, sequential therapy, bismuth quadruple therapy and concomitant therapy. The course of treatment is 14 days. The primary outcome measure was the Hp eradication rate at 4-6 weeks after completion of treatment which was confirmed by a negative of 13 UBT. Secondary outcome measures included side effects, impact factor and changes of microbiome after the therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T-group | Experimental | Drug: triple therapyT-group(triple therapy) |
| S-group | Experimental | Drug: sequential therapyS-group( sequential therapy) |
| B-group | Experimental | Drug: bismuth quadruple therapyB-group( bismuth quadruple therapy ) |
| C-group | Experimental | Drug: concomitant therapyC-group( concomitant therapy) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children 6-18 years of age who were referred for upper endoscopy and confirmed to have Hp infection
Key exclusion criteria (1 listed)
- patients were excluded if they had taken proton pump inhibitors, H2-receptor antagonists or antibiotics in the 4 weeks prior to the study. Patients with known antibiotic allergy,hepatic impairment or kidney failure were also excluded. Patients who received Hp therapy before were also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| triple therapyOmeprazole+Amoxicillin+Clarithromycin | Drug | T-group |
| sequential therapythe first 7 days : Omeprazole+Amoxicillin, the last 7 days: Omeprazole+Clarithromycin+Metronidazole | Drug | S-group |
| bismuth quadruple therapyOmeprazole+Amoxicillin+Metronidazole+Colloidal Bismuth Subcitrate | Drug | B-group |
| concomitant therapyOmeprazole+Amoxicillin+Clarithromycin+Metronidazole | Drug | C-group |
Primary outcome
13C-UBT
Time frame: 13C-UBT was assessed at 4-6 weeks after completion of therapy
13C-UBT was used to determine whether Hp treatments was successful
8 secondary outcomes
side effects
Time frame: assess at 2,4-6weeks after completion of the therapy
changes of Shannon diversity indices for gut microbiome
Time frame: assess at 0,2,4-6weeks after completion of the therapy
changes of OTU for gut microbiome
Time frame: assess at 0,2,4-6weeks after completion of the therapy
changes of abundances for gut microbiome
Time frame: assess at ,2,4-6weeks after completion of the therapy
CYP2C19 gene that impact the metabolism of PPI
Time frame: detect the gene before the therapy
virulence gene-cagA
Time frame: detect the gene before the therapy
virulence gene-vacA
Time frame: detect the gene before the therapy
patient compliance
Time frame: assess compliance 2 weeks after the therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Background: PubMed 28541262Jones NL, Koletzko S, Goodman K, Bontems P, Cadranel S, Casswall T, Czinn S, Gold BD, Guarner J, Elitsur Y, Homan M, Kalach N, Kori M, Madrazo A, Megraud F, Papadopoulou A, Rowland M; ESPGHAN, NASPGHAN. Joint ESPGHAN/NASPGHAN Guidelines for the Management of Helicobacter pylori in Children and Adolescents (Update 2016). J Pediatr Gastroenterol Nutr. 2017 Jun;64(6):991-1003. doi: 10.1097/MPG.0000000000001594.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triple therapy, sequential therapy and bismuth quadruple therapy in people with Helicobacter Infections, run by Ying HUANG 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 28 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Zhou, master (13917394900, nnyyhhs@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
13C-UBT (time frame: 13C-UBT was assessed at 4-6 weeks after completion of therapy). 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 NCT03365609, which also lists 1 linked publication.
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 28 Feb 2025.