Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri

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.

Study Overview

• Status: Unknown
• Conditions: Dyspepsia; Helicobacter Pylori Infection
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Lactobacillus reuteri

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Centro Regional para el Estudio de las Enfermedades Digestivas, Facultad de Medicina y Hospital Universitario, UANL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Lactobacillus reuteri; L. reuteri is one species of lactobacillus that naturally inhabits the gastrointestinal tract of humans	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
PLACEBO_COMPARATOR: placebo; Placebo will be delivered in a chewable tablet form (1.5g per dose)	Dietary supplement: Placebo; placebo; Other Names: bioGaia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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	101 days

Collaborators and Investigators

• Sponsor: Centro Regional para el Estudio de las Enfermedades Digestivas
• Collaborators: BioGaia AB
• Investigators: Principal Investigator: Francisco J Bosques, MD PhD, Centro Regional para el Estudio de las Enfermedades Digestivas

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ANTICIPATED): September 1, 2011
• Study Completion (ANTICIPATED): January 1, 2012

Study Registration Dates

• First Submitted: December 7, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (ESTIMATE): December 9, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 22, 2011
• Last Update Submitted That Met QC Criteria: June 21, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Eradication therapy; Lactobacillus reuteri; Dyspeptic symptoms
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Signs and Symptoms, Digestive; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Dyspepsia; Infections; Communicable Diseases; Helicobacter Infections
• Other Study ID Numbers: lactobacilos vs helicobacter