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

December 7, 2009
June 21, 2011
December 2009
September 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01028690 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Helicobacter Pylori Infection
  • Dyspepsia
  • 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
  • Dietary Supplement: Placebo
    placebo
    Other Name: bioGaia
  • Active Comparator: Lactobacillus reuteri
    L. reuteri is one species of lactobacillus that naturally inhabits the gastrointestinal tract of humans
    Intervention: Dietary Supplement: Lactobacillus reuteri
  • Placebo Comparator: placebo
    Placebo will be delivered in a chewable tablet form (1.5g per dose)
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
January 2012
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01028690
lactobacilos vs helicobacter
No
Francisco Javier Bosques Padilla, Centro Regional Para el Estudio de las Enfermedades Digestivas
Centro Regional para el Estudio de las Enfermedades Digestivas
BioGaia AB
Principal Investigator: Francisco J Bosques, MD PhD Centro Regional para el Estudio de las Enfermedades Digestivas
Centro Regional para el Estudio de las Enfermedades Digestivas
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP