Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
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| Mexico | |
| Centro Regional para el Estudio de las Enfermedades Digestivas, Facultad de Medicina y Hospital Universitario, UANL | |
| Monterrey, Nuevo León, Mexico, 64460 | |
| 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 May 23, 2013