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Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri

Primary Purpose

Helicobacter Pylori Infection, Dyspepsia

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Lactobacillus reuteri
Placebo
Sponsored by
Centro Regional para el Estudio de las Enfermedades Digestivas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, Eradication therapy, Lactobacillus reuteri, Dyspeptic symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centro Regional para el Estudio de las Enfermedades Digestivas, Facultad de Medicina y Hospital Universitario, UANL

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lactobacillus reuteri

placebo

Arm Description

L. reuteri is one species of lactobacillus that naturally inhabits the gastrointestinal tract of humans

Placebo will be delivered in a chewable tablet form (1.5g per dose)

Outcomes

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

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

Full Information

First Posted
December 7, 2009
Last Updated
June 21, 2011
Sponsor
Centro Regional para el Estudio de las Enfermedades Digestivas
Collaborators
BioGaia AB
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1. Study Identification

Unique Protocol Identification Number
NCT01028690
Brief Title
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

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Centro Regional para el Estudio de las Enfermedades Digestivas
Collaborators
BioGaia AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection, Dyspepsia
Keywords
Helicobacter pylori, Eradication therapy, Lactobacillus reuteri, Dyspeptic symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus reuteri
Arm Type
Active Comparator
Arm Description
L. reuteri is one species of lactobacillus that naturally inhabits the gastrointestinal tract of humans
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be delivered in a chewable tablet form (1.5g per dose)
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri
Other Intervention Name(s)
Progastria
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
bioGaia
Intervention Description
placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco J Bosques, MD PhD
Organizational Affiliation
Centro Regional para el Estudio de las Enfermedades Digestivas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Regional para el Estudio de las Enfermedades Digestivas, Facultad de Medicina y Hospital Universitario, UANL
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

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Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri

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