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Gastric PolypPhase 4NCT03065868

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

A Phase 4 study testing H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin) in people with Gastric Polyp and Helicobacter Pylori Infection, run by Kyungpook National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluation of the effect of H. pylori eradication on regression of H. pylori-related gastric polyp (Ranomized controlled trial) 1. Study design: open labeled RCT 2. Study group H. pylori eradication group (N=17), non-eradication group (N=15) 3. Treatment plan 1. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Gastric Polyp, Helicobacter Pylori Infection
What is being tested?
H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSouth Korea
Study dates
9 Dec 2015to 30 Apr 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Su Youn Nam

    Daegu, 41404

Other trials in South Korea

About this study

Official title: Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp (Randomized Controlled Study)

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

  1. Study design: open labeled RCT
  2. Study group H. pylori eradication group (N=17), non-eradication group (N=15)
  3. Treatment plan
  4. Baseline EGD : 0.3-1cm sized polyp - bx \& CLO test (antrum \& body) ==> if H. pylori positive and eligible patients, randomization
  5. Triple therapy
  6. UBT (4week after eradication)
  7. Follow-up EGD: gross finding, CLO test
  8. Evaluation of polyp regression
  9. disappear
  10. regression over 50% (size, number)
  11. no change or increase (size, number)
Read the detailed description

(A) Study population

  1. inclusion HP-realetd polyp polyp size with 0.3cm-1cm 20 yr - 70yr
  2. exclusion peptic ulcer, healing stage or acute stage recent use of PPI within 4weeks Liver cirrhosis, renal insufficiency, other serious chronic or acute disease current infection of other bacteria, virus, or fungus cancer, psychologic disease heavy drinker drug abuser pregnant women, Penicillin allergy, digoxin, antifungal, wafarin previosu H. pylori eradication enroll gastric polyp with bleeding or malignant transformation tiny polyp less than 3mm. (B) Study method
  3. Study design: open labeled RCT
  4. Study group H. pylori eradication group (N=17), non-eradication group (N=15)
  5. Treatment plan
  6. Baseline EGD: 0.3-1cm sized polyp - bx \& CLO test (antrum \& body) ==> if H. pylori positive and eligible patients, randomization
  7. Triple therapy
  8. UBT (4week after eradication) if eradication failure in triple therapy, 2nd line treatment (metroniazole based quadraple therpay) and the UBT (4week after eradication)
  9. Follow-up EGD (3-9M): gross finding, CLO test
  10. Evaluation of polyp regression
  11. disappear
  12. regression over 50% (size, number)
  13. no change or increase (size, number)
  14. Statistical analysis
  15. Chi-square test to compare polyp regression between treatment \& control group.
  16. t-test to compare continuous variables between treatment \& control group.
  17. Paired T-test to compare the size between baseline and follow-up EGD.
  18. Regression analysis: univariate \& multivariate analysis.
Being tested
H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)
Keywords
gastric polyp, Helicobacter pylori eradication
Medical subject headings
Polyposis, Gastric

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Triple Therapy

    1. pylori eradication (Triple Therapy) as first line treatment if eradication failure, quadruple therpy will be provided as 2nd line treatment
Study groups in NCT03065868
Study groupRoleWhat they receive
eradictaionExperimentalH. pylori eradication group
Receives: Drug: H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)
non-eradicationNo interventionH. pylori non-eradication group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 24months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2017
  2. Study start9 Dec 2015
  3. Primary completion30 Apr 2019
  4. Study completion30 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
open labelled randomized controlled trial. randomization : 2015 September
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03065868
Sponsor's protocol ID
KNUMC_15-1045
Status last verified
Sep 2019
First submitted
18 Feb 2017
Last updated
26 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31974914

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin) in people with Gastric Polyp and Helicobacter Pylori Infection, run by Kyungpook National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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% (time frame: up to 24months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03065868, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.

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