Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp

NCT03065868 | Completed Phase 4 DMC

• 1 other identifier: KNUMC_15-1045
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the effect of H. pylori eradication on regression of H. pylori-related gastric polyp (Ranomized controlled trial)

1. 1.Study design: open labeled RCT
2. 2.Study group H. pylori eradication group (N=17), non-eradication group (N=15)
3. 3.Treatment plan
4. 4.Baseline EGD
5. 5.Triple therapy
6. 6.UBT (4week after eradication)
7. 7.Follow-up EGD: gross finding, CLO test
8. 8.Evaluation of polyp regression
9. 9.disappear
10. 10.regression over 50% (size, number)
11. 11.no change or increase (size, number)

Conditions

Gastric Polyp; Helicobacter Pylori Infection

Keywords

gastric polyp; Helicobacter pylori eradication

Outcome Measures

Primary Outcomes (1)

• Compare regression rate of gastric polyps between H. pylori eradication and non-eradication groups. Regression of gastric polyp: one of below 1) Disappearance of gastric polyp 2) Reduction of polyp size over 50%

  Evaluation of the effect of H. pylori eradication on the regression of H. pylori associated gastric polyp Study group 1. H. pylori eradication 2. H. pylori non-eradication Definition of gastric polyp change: 1. Disappearance of gastric polyp 2. Reduction of polyp size over 50% 3. No change of size or increased size

  up to 24months

Study Arms (2)

eradictaion

EXPERIMENTAL

H. pylori eradication group

Drug: H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)

non-eradication

NO INTERVENTION

H. pylori non-eradication group

Interventions

H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin) DRUG

H. pylori eradication (Triple Therapy) as first line treatment if eradication failure, quadruple therpy will be provided as 2nd line treatment

Also known as: Triple Therapy

eradictaion

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gastric polyp with current infection of H. pylori
• Gastric polyp size with 3mm-10mm
• Age of 20 yr - 70yr

You may not qualify if:

• Gastric ulcer ir duodenal ulcer (healing stage or acute stage)
• Use of PPI within 4weeks
• Liver cirrhosis, renal insufficiency, other serious chronic or acute disease
• Current infection of other bacteria, virus, or fungus
• Any cancer, psychologic disease
• Heavy drinker
• Drug abuser
• Pregnant women
• Penicillin allergy
• Use of digoxin, antifungal, wafarin
• Previous H. pylori eradication
• Gastric polyp with bleeding or malignant transformation
• Tiny polyp less than 3mm.

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

Study Sites (1)

Su Youn Nam

Daegu, 41404, South Korea

Location

Related Publications (1)

• Nam SY, Lee SW, Jeon SW, Kwon YH, Lee HS. Helicobacter pylori Eradication Regressed Gastric Hyperplastic Polyp: A Randomized Controlled Trial. Dig Dis Sci. 2020 Dec;65(12):3652-3659. doi: 10.1007/s10620-020-06065-0. Epub 2020 Jan 23.

  PMID: 31974914 DERIVED

MeSH Terms

Conditions

Polyposis, Gastric

Interventions

Clarithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Su Youn Y Nam, MD, PhD

  Kyungpook National University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Model Details: open labelled randomized controlled trial. randomization : 2015 September

Study Record Dates

• First Submitted: February 18, 2017
• First Posted: February 28, 2017
• Study Start: December 9, 2015
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)