Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri

NCT ID: NCT01028690

Last Updated: 2011-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-01-31

Brief Summary

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.

Detailed 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.

Conditions

Helicobacter Pylori Infection; Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lactobacillus reuteri

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

Group Type: ACTIVE_COMPARATOR

Lactobacillus reuteri

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

placebo

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Progastria; bioGaia

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioGaia AB

INDUSTRY

Sponsor Role: collaborator

Centro Regional para el Estudio de las Enfermedades Digestivas

OTHER

Sponsor Role: lead

Responsible Party

Centro Regional Para el Estudio de las Enfermedades Digestivas

Principal Investigators

Francisco J Bosques, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centro Regional para el Estudio de las Enfermedades Digestivas

Locations

Centro Regional para el Estudio de las Enfermedades Digestivas, Facultad de Medicina y Hospital Universitario, UANL

Monterrey, Nuevo León, Mexico

Countries

Mexico

Other Identifiers

lactobacilos vs helicobacter

Identifier Type: -

Identifier Source: org_study_id