Helicobacter Pylori InfectionPhase 4NCT03730766
Analysis of the Impact of Helicobacter Pylori on Salivary Microbiome in Adults
A Phase 4 study testing Esomeprazole, Amoxicillin and Bismuth Potassium Citrate in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Helicobacter pylori (H. pylori), a bacteria transmitted from human to human through upper digestive tract as well as fecal-oral transmission, had infected more than half of people around the world. However, the quantity of H. pylori in oral cavity and its influence on oral microbiota remains to be unclear. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Esomeprazole, Amoxicillin and Bismuth Potassium Citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 20 Nov 2018
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with non-ulcer functional dyspepsia or peptic ulcer disease
- Ability and willingness to participate in the study and to sign and give informed consent
- Received both endoscopy and 13C urea breath test (13C-UBT) before enrolled
Who cannot join
- Less than 18 years old
- With previous gastric surgery
- Major systemic diseases
- Pregnancy or lactation
- Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
- The use of antibiotics or PPI within 2 months before the study
- The presence of dental carious or any untreated cavitated carious lesions and oral abscesses
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Yingjie Ji, M.D, 86+15800575527, jiyingjie39@outlook.com
Hong Lu, M.D., Ph.D
About this study
Official title: Analysis of the Impact of Helicobacter Pylori Infection and Eradication on Salivary Microbiome in Adults by 16S Pyrosequencing
Helicobacter pylori (H. pylori), a bacteria transmitted from human to human through upper digestive tract as well as fecal-oral transmission, had infected more than half of people around the world. However, the quantity of H. pylori in oral cavity and its influence on oral microbiota remains to be unclear. The aim of the present study was to examine the effects of H. pylori infection as well as its eradication on oral microbiota.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Esomeprazole, Amoxicillin, Bismuth Potassium Citrate
- Keywords
- helicobacter pylori, saliva microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Proton pump inhibitor
AmoxicillinDrug
Also called Metronidazole
Antibiotics for H. pylori eradication
Bismuth Potassium CitrateDrug
Gastric mucosal protective drug with anti-H. pylori effect
| Study group | Role | What they receive |
|---|---|---|
| Bismuth Plus triple Therapy | Experimental | Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days Receives: Drug: Esomeprazole; Drug: Amoxicillin; Drug: Bismuth Potassium Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of saliva microbiota after eradication
Two months after completion of therapy, saliva microbiota was assessed by 16S rDNA Pyrosequencing.
Measured: Two months after completion of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Aug 2018
- Primary completion15 Nov 2018 (estimated)
- Study completion20 Nov 2018 (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 Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Lu, MD, Shanghai Jiao Tong University School of Medicine
- Investigators
- Hong Lu, M.D., Ph.D., Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730766
- Sponsor's protocol ID
- rjyy20180801
- Status last verified
- Nov 2018
- First submitted
- 2 Nov 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ji Y, Liang X, Lu H. Analysis of by high-throughput sequencing: Helicobacter pylori infection and salivary microbiome. BMC Oral Health. 2020 Mar 20;20(1):84. doi: 10.1186/s12903-020-01070-1.
PubMed 32197614
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Impact of Helicobacter Pylori Infection and Eradication on Salivary Microbiome in Adults by 16S Pyrosequencing
- ClinicalTrials.gov ID
- NCT03730766
- Acronym / sponsor ID
- rjyy20180801
- Conditions
- Helicobacter Pylori Infection
- Keywords
- helicobacter pylori, saliva microbiota
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 15 Nov 2018 (estimated)
- Study completion
- 20 Nov 2018 (estimated)
- First posted
- 5 Nov 2018 (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.
Helicobacter pylori (H. pylori), a bacteria transmitted from human to human through upper digestive tract as well as fecal-oral transmission, had infected more than half of people around the world. However, the quantity of H. pylori in oral cavity and its influence on oral microbiota remains to be unclear. The aim of the present study was to examine the effects of H. pylori infection as well as its eradication on oral microbiota.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bismuth Plus triple Therapy | Experimental | Drug: Esomeprazole, Drug: Amoxicillin, Drug: Bismuth Potassium CitrateEsomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants with non-ulcer functional dyspepsia or peptic ulcer disease
- Ability and willingness to participate in the study and to sign and give informed consent
- Received both endoscopy and 13C urea breath test (13C-UBT) before enrolled
Key exclusion criteria (7 listed)
- Less than 18 years old
- With previous gastric surgery
- Major systemic diseases
- Pregnancy or lactation
- Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
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 |
|---|---|---|
| EsomeprazoleProton pump inhibitor | Drug | Bismuth Plus triple Therapy |
| AmoxicillinAlso: MetronidazoleAntibiotics for H. pylori eradication | Drug | Bismuth Plus triple Therapy |
| Bismuth Potassium CitrateGastric mucosal protective drug with anti-H. pylori effect | Drug | Bismuth Plus triple Therapy |
Primary outcome
Change of saliva microbiota after eradication
Time frame: Two months after completion of therapy.
Two months after completion of therapy, saliva microbiota was assessed by 16S rDNA Pyrosequencing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Derived from this study: PubMed 32197614Ji Y, Liang X, Lu H. Analysis of by high-throughput sequencing: Helicobacter pylori infection and salivary microbiome. BMC Oral Health. 2020 Mar 20;20(1):84. doi: 10.1186/s12903-020-01070-1.
- 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. This study is not recruiting at the moment.
Hong Lu, M.D., Ph.D. principal investigator
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole, Amoxicillin and Bismuth Potassium Citrate in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Nov 2018. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingjie Ji, M.D. (86+15800575527, jiyingjie39@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of saliva microbiota after eradication (time frame: Two months 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 NCT03730766, 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 5 Nov 2018.