Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-31 @ 11:51 AM
Study NCT ID:
NCT01456728
Status:
COMPLETED
Last Update Posted:
2013-09-10
First Post:
2011-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactobacillus Reuteri ProGastria in Helicobacter Pylori-infected Adult Subjects on Proton Pump Inhibitors
Sponsor:
St Marina University Hospital, Varna, Bulgaria
Organization:
Study Overview
Official Title:
Efficacy of Dietary Supplementation With Lactobacillus Reuteri ProGastria in Helicobacter Pylori-infected Adult Subjects Treated Only With Proton Pump Inhibitors
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to confirm that simultaneous use of L. reuteri ProGastria and omeprazole for 28 days can eradicate H. pylori in humans in the absence of antibiotics.
Detailed Description:
Helicobacter pylori colonises an estimated 50% of the world´s population. Despite clear clinical guidelines on the treatment of this infection there is a drive to find alternative ways to control this infection in a wider perspective without the complications of induction of antibiotic resistance in the pathogen. A good alternative is to use probiotics.
Lactic acid bacteria and in particular lactobacilli have been studied for their effects in humans infected with H. pylori with some success in reducing the infection load. Studies using supplementation with L. reuteri in both symptomatic and non-symptomatic H. pylori-infected subjects show a clear reduction of infection load after 4 weeks of use and this was concomitant with a reduction in symptoms associated with the infection. Further, dietary supplementation with L. reuteri during and after the period of H. pylori eradication therapy has also been shown to reduce the side effects of this therapy without affecting the degree of eradication.
Lactic acid bacteria and in particular lactobacilli have been studied for their effects in humans infected with H. pylori with some success in reducing the infection load. Studies using supplementation with L. reuteri in both symptomatic and non-symptomatic H. pylori-infected subjects show a clear reduction of infection load after 4 weeks of use and this was concomitant with a reduction in symptoms associated with the infection. Further, dietary supplementation with L. reuteri during and after the period of H. pylori eradication therapy has also been shown to reduce the side effects of this therapy without affecting the degree of eradication.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: