Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Centro Regional para el Estudio de las Enfermedades Digestivas.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
BioGaia AB
Information provided by:
Centro Regional para el Estudio de las Enfermedades Digestivas
ClinicalTrials.gov Identifier:
NCT01028690
First received: December 7, 2009
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Helicobacter Pylori Infection
Dyspepsia
Dietary Supplement: Lactobacillus reuteri
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri

Resource links provided by NLM:


Further study details as provided by Centro Regional para el Estudio de las Enfermedades Digestivas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Progastria
Placebo Comparator: placebo
Placebo will be delivered in a chewable tablet form (1.5g per dose)
Dietary Supplement: Placebo
placebo
Other Name: bioGaia

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028690

Locations
Mexico
Centro Regional para el Estudio de las Enfermedades Digestivas, Facultad de Medicina y Hospital Universitario, UANL
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Centro Regional para el Estudio de las Enfermedades Digestivas
BioGaia AB
Investigators
Principal Investigator: Francisco J Bosques, MD PhD Centro Regional para el Estudio de las Enfermedades Digestivas
  More Information

No publications provided

Responsible Party: Francisco Javier Bosques Padilla, Centro Regional Para el Estudio de las Enfermedades Digestivas
ClinicalTrials.gov Identifier: NCT01028690     History of Changes
Other Study ID Numbers: lactobacilos vs helicobacter
Study First Received: December 7, 2009
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board
Mexico: Ethics Committee

Keywords provided by Centro Regional para el Estudio de las Enfermedades Digestivas:
Helicobacter pylori
Eradication therapy
Lactobacillus reuteri
Dyspeptic symptoms

Additional relevant MeSH terms:
Dyspepsia
Helicobacter Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 15, 2014