Effect of Oral Helicobacter Pylori Infection on the Efficacy of Gastroluminal Helicobacter Pylori Eradication Therapy

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Xijing Hospital of Digestive Diseases

Status and phase

Enrolling
Phase 4

Conditions

Helicobacter Pylori

Treatments

Drug: Standard bismuth quadruple

Study type

Interventional

Funder types

Other

Identifiers

NCT05790525
KY20232027-C-1-B

Details and patient eligibility

About

The aim of this study is to assess the effect of oral Helicobacter pylori infection on the efficacy of gastric Helicobacter pylori infection eradication. Patients diagnosed with gastric Helicobacter pylori infection are tested for oral Helicobacter pylori and given standard bismuth quadruple therapy, with a urea breath test, a rapid urease test, or a Helicobacter pylori stool antigen test to confirm gastric Helicobacter pylori eradication at week 6 follow-up, and an oral Helicobacter pylori test kit to confirm oral Helicobacter pylori eradication.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age between 18~70 ,both gender.
  • Initial diagnosis of stomach Helicobacter pylori infection or never had Helicobacter pylori infection.
  • Have not received dental care or systemic periodontal basic treatment in the past 1 year.

Exclusion criteria

  • Those who have contraindications to the drugs used in this institute or are allergic to the drugs used.
  • There is serious organ damage and complications (such as cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
  • Ongoing use of antiulcer medications (including PPIs taken within 2 weeks before Helicobacter pylori infection testing), antibiotics, or bismuth complexes (more than 3 times/week before screening).
  • Those with severe oral diseases and malignant tumors of the mouth.
  • Women planning pregnancy, pregnancy and breastfeeding.
  • Previously had upper gastrointestinal surgery.
  • Those who do not take their medication on time.
  • Refusal to sign informed consent.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Both gastric and oral Helicobacter pylori are positive
Other group
Treatment:
Drug: Standard bismuth quadruple
Positive for Helicobacter pylori for gastric and negative for Helicobacter pylori for oral cavity
Other group
Treatment:
Drug: Standard bismuth quadruple

Trial contacts and locations

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Central trial contact

Jiaojiao Cao; Yongquan Shi, PhD

Data sourced from clinicaltrials.gov

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