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Clinical Trials/CTRI/2011/08/001968
CTRI/2011/08/001968Completed未知

A randomized double blind placebo controlled trial of NR/GG/01 (GutGard?) in the management of Helicobacter pylori

ICS CO LTD0 sites100 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
未知
Status
Completed
Sponsor
Enrollment
100

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • 1. Subjects aged 18 - 45 years
  • 2. H. pylori 13C urea breath test
  • (positive Greaterthan/Equalto 4.0 Plus/Minus 0.4 DOB)
  • 3. H. pylori positive in stool test

Exclusion Criteria

  • 1. History/Diagnosed with bleeding duodenal ulcer
  • 2. Advanced chronic illness that would impair follow-up or monitoring.
  • 3. Pregnancy or breast feeding.
  • 4. Previous surgery for ulcers.
  • 5. History of MALT lymphoma
  • 6. First level relatives of gastric cancer patients
  • 7. Subjects with previous history of gastroesophageal reflux
  • 8. Subjects with concomitant symptoms of the irritable bowel syndrome.
  • 9. Drug and alcohol abuse.
  • 10. Use of oral antibiotics and/or PPIs and/or H2-antagonists during the 2 weeks prior to ingestion of the study product
  • 11. Patients using non-steroidal anti-inflammatory drugs, steroids, bismuth preparation
  • 12. Mental illness or dementia.
  • 13. Participation in other clinical trials

Investigators

Sponsor
ICS CO LTD

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