H. Pylori Treatment Between Modified Quadruple Regimen and Tailored Therapy

NCT05002595 | Completed DMC

• 1 other identifier: SCH-HP-2021
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has increased worldwide. Eradication failure using triple therapy is strongly associated with CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. pylori eradication which emphasizes on predicting individual drug responses before treatment. Dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection and identify CAM resistance. The use of DPO-PCR has increased the tailored H. pylori eradication rate in Korea. If DPO-PCR testing is not available, a 14-day modified bismuth-containing quadruple regimen is recommended as a first-line H. pylori eradication. However, there is no comparison study between modified quadruple therapy and tailored eradication based on the presence of CAM resistance using DPO-PCR.

Conditions

H. Pylori Infection

Outcome Measures

Primary Outcomes (1)

• H. pylori infection status

  Rate of successful H. pylori eradication

  6 weeks

Study Arms (2)

Modified quadruple therapy

pantoprazole 40mg bid, amoxicillin 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 14 days

Drug: H. pylori eradication

Tailored eradication

pantoprazole 40mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid or pantoprazole 40mg bid, tetracycline 1000mg bid, metronidazole 750mg bid, bismuth subcitrate 600mg bid for 7 days

Drug: H. pylori eradication

Interventions

H. pylori eradication DRUG

Antimicrobial agents for H. pylori eradication

Modified quadruple therapy; Tailored eradication

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

H. pylori-infected patients

You may qualify if:

• Gastroscopy can be performed
• H. pylori test and pathological analysis can be performed

You may not qualify if:

• Age \< 20 or \> 80 years
• Anemia (serum hemoglobin level \< 10 g/dL)
• Severe systemic disease
• Advanced chronic liver disease
• Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
• History of H. pylori eradication
• History of gastric surgery
• Recent history of upper gastrointestinal bleeding

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Digestive Disease Center, Soonchunhyang University Hospital

Seoul, 04401, South Korea

Location

Related Publications (1)

• Cho JH, Jin SY, Park S. Comparison of tailored Helicobacter pylori eradication versus modified bismuth quadruple therapy in Korea: a randomized controlled trial. Expert Rev Anti Infect Ther. 2022 Jun;20(6):923-929. doi: 10.1080/14787210.2022.2017280. Epub 2021 Dec 20.

  PMID: 34883037 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimen would be obtained for urease test (commercial name: CLOtest) or molecular test (DPO-PCR).

Study Officials

• Jun-Hyung Cho, M.D.

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 12, 2021
• Study Start: January 1, 2018
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)