Analysis of the Impact of Helicobacter Pylori on Salivary Microbiome in Adults

NCT ID: NCT03730766

Last Updated: 2018-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2018-11-20

Brief Summary

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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.

Detailed Description

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Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Bismuth Plus triple Therapy

Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

Proton pump inhibitor

Amoxicillin

Intervention Type DRUG

Antibiotics for H. pylori eradication

Bismuth Potassium Citrate

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Interventions

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Esomeprazole

Proton pump inhibitor

Intervention Type DRUG

Amoxicillin

Antibiotics for H. pylori eradication

Intervention Type DRUG

Bismuth Potassium Citrate

Gastric mucosal protective drug with anti-H. pylori effect

Intervention Type DRUG

Other Intervention Names

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Metronidazole

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hong Lu, MD

Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Lu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Locations

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Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yingjie Ji, M.D.

Role: CONTACT

86+15800575527

Facility Contacts

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Yingjie Ji, M.D

Role: primary

86+15800575527

References

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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.

Reference Type DERIVED
PMID: 32197614 (View on PubMed)

Other Identifiers

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rjyy20180801

Identifier Type: -

Identifier Source: org_study_id

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