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The Effect of Time Intervals for Rescue Treatment on Eradication Effect of Helicobacter Pylori Infection

S

Shandong University

Status

Not yet enrolling

Conditions

Helicobacter Pylori Infection

Treatments

Other: Remedial treatment within 3 to 6 months
Other: Remedial treatment after 12 months
Other: Remedial treatment within 6 to 12 months
Other: Remedial treatment within 3 months

Study type

Observational

Funder types

Other

Identifiers

NCT05620602
2022-SDU-QILU-G007

Details and patient eligibility

About

The researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. After rescue therapy, evaluating the effect of retreatment interval on eradication effect of Helicobacter pylori infection.

Full description

The researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. Record the interval between the last eradication therapy and this time,6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculating the eradication rates, adverse reaction rates, patient compliance of each group. Evaluating the effect of retreatment interval on eradication effect of Helicobacter pylori infection.

Enrollment

628 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged 18-70.
  • Patients with H.pylori infection (Positive for any of the following: 13C/14C-urea breath test, histopathology test, rapid urease test, stool H.pylori antigen test).
  • Patients who have previously received helicobacter pylori eradication therapy and failed.

Exclusion criteria

  • Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
  • Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
  • Patients with active gastrointestinal bleeding.
  • Patients with a history of upper gastrointestinal surgery.
  • Patients allergic to treatment drugs.
  • Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
  • Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
  • Patients who are unwilling or incapable to provide informed consents.

Trial design

628 participants in 4 patient groups

Remedial treatment within 3 months
Treatment:
Other: Remedial treatment within 3 months
Remedial treatment within 3 to 6 months
Treatment:
Other: Remedial treatment within 3 to 6 months
Remedial treatment within 6 to 12 months
Treatment:
Other: Remedial treatment within 6 to 12 months
Remedial treatment after 12 months
Treatment:
Other: Remedial treatment after 12 months

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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