Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri

Helicobacter Pylori Infection Clinical Trial

Official title:

Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01028690
• Other study ID #: lactobacilos vs helicobacter
• Status: Active, not recruiting
• Phase: N/A
• First received: December 7, 2009
• Last updated: June 21, 2011
• Start date: December 2009
• Est. completion date: January 2012

Study information

• Verified date: June 2011
• Source: Centro Regional para el Estudio de las Enfermedades Digestivas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardMexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

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
• Placebo
placebo

Locations

Country	Name	City	State
Mexico	Centro Regional para el Estudio de las Enfermedades Digestivas, Facultad de Medicina y Hospital Universitario, UANL	Monterrey	Nuevo León

Sponsors (2)

Lead Sponsor	Collaborator
Centro Regional para el Estudio de las Enfermedades Digestivas	BioGaia AB

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes