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
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