Clinical trial NCT01028690: Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri
Official title: Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Dyspepsia
Keywords: Helicobacter pylori
Eradication therapy
Lactobacillus reuteri
Dyspeptic symptoms
Lead sponsor: Centro Regional para el Estudio de las Enfermedades Digestivas
Sponsor class: OTHER
Collaborators: name: BioGaia AB
First posted: 2009-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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
timeFrame: 28 days
Secondary outcomes:
measure: 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
timeFrame: 101 days
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Centro Regional para el Estudio de las Enfermedades Digestivas, Facultad de Medicina y Hospital Universitario, UANL
state: Nuevo León
Study officials:
affiliation: Centro Regional para el Estudio de las Enfermedades Digestivas
name: Francisco J Bosques, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: