This trial is active, not recruiting.

Conditions helicobacter pylori infection, dyspepsia
Treatments lactobacillus reuteri, placebo
Sponsor Centro Regional para el Estudio de las Enfermedades Digestivas
Collaborator BioGaia AB
Start date December 2009
End date September 2011
Trial size 100 participants
Trial identifier NCT01028690, lactobacilos vs helicobacter


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
L. reuteri is one species of lactobacillus that naturally inhabits the gastrointestinal tract of humans
lactobacillus reuteri Progastria
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
(Placebo Comparator)
Placebo will be delivered in a chewable tablet form (1.5g per dose)
placebo bioGaia

Primary Outcomes

Assessed decrease H. pylori gastric load by histology after 28 days compared to placebo and assessed by 13C-UBT before and after 28 days use of L. compared to placebo
time frame: 28 days

Secondary Outcomes

To decrease dyspeptic symptoms before, during and after eradication therapy as assessed by a gastro-intestinal symptom rating scoring within and between L. reuteri and placebo-supplemented subjects
time frame: 101 days

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri
Principal investigator Francisco J Bosques, MD PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Centro Regional para el Estudio de las Enfermedades Digestivas.