Trial | NCT01028690  Report issue

Official Title

Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
Helicobacter pylori colonizes approximately to 50% of the world-wide population.

There is an exigency to find routes alternating to control the infection with an ample perspective but without the complications of induction of resistance to antibiotics. Supplement dietetic with Lactobacillus reuteri (L. reuteri) in humans takes to the colonization of epithelium gastric and this, combined with the observation of which L. reuteri has the capacity to inhibit the growth of H. Pylori and its union to the gastric mucosa, indicates the potential that the native human bacteria control and influence in the colonization in humans.

The acid-lactic bacteria (in particular the lactobacillus) have been studied by their effects in humans infected with H. Pylori with some success to reduce the load of bacteria Studies using supplements with L. reuteri as much in infected symptomatic patients as asymptomatic with H. pylori showed a clear reduction of the load of bacteria after 4 weeks of use and this was concordant with a reduction in the symptoms associated to the infection.
The objective of this study is to determine if the dietetic supplementation with a combination of the stock of L. Reuteri (L. reuteri Progastria) is effective to control the load of bacteria and the consequences of the infection in patients infected with H. pylori.
Study Started
Dec 31
2009
Primary Completion
Sep 30
2011
Anticipated
Study Completion
Jan 31
2012
Anticipated
Last Update
Jun 22
2011
Estimate

Dietary Supplement Lactobacillus reuteri

Lactobacillus reuteri is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475; will be delivered at a dose of 1x108 CFU of each strain. One dose is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day. Will be taken daily throughout the entire study, from the day of inclusion to the final analysis at the end of follow-up after eradication therapy. Will be delivered either in a chewable tablet form

  • Other names: Progastria

Dietary Supplement Placebo

placebo

  • Other names: bioGaia

Lactobacillus reuteri Active Comparator

L. reuteri is one species of lactobacillus that naturally inhabits the gastrointestinal tract of humans

placebo Placebo Comparator

Placebo will be delivered in a chewable tablet form (1.5g per dose)

Criteria 

Inclusion Criteria:

Subjects aged 18 - 65 years
Infection with H. pylori defined as ∆ > 20 ppm in the UBT test
Non-ulcer dyspepsia
No earlier eradication therapy for H. pylori infection
Written informed consent
Stated availability throughout the entire study period
Mental ability to understand and willingness to fulfil all the details of the protocol

Exclusion Criteria:

Duodenal or gastric ulcer
MALT lymphoma
Penicillin allergy
Gastric resection (at any time)
First level relatives of gastric cancer patients
Absence of GI symptoms
Use of NSAIDs, aspirin or other anti-inflammatory drugs within 1 week (for occasional use) or 3 weeks (for chronic use) of inclusion
Use of oral antibiotics and/or PPIs and/or H2-antagonists during the 2 weeks prior to ingestion of the study product
Pregnancy
Participation in other clinical trials
No Results Posted