Control of Helicobacter Pylori Infection by Probiotics
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Purpose
Helicobacter pylori colonises an estimated 50% of the world´s population (Taylor & Blaser, 1991; Go, 2002). Despite clear clinical guidelines on the treatment of this infection (Malfertheiner et al. 2007) there is a drive to find alternative ways to control this infection in a wider perspective without the complications of induction of antibiotic resistance in the pathogen.
L. reuteri has been widely studied in clinical trials and has been shown to have probiotic, health-promoting effects in both adults and children (Connolly 2004; Casas & Dobrogosz, 2000). L. reuteri has been shown in numerous studies to be safe for human consumption and it has been shown to colonise the human gastrointestinal tract (Wolf et al., 1995, Valeur et al., 2004).
Studies using supplementation with L. reuteri in both symptomatic and non-symptomatic H. pylori-infected subjects show a clear reduction of infection load after 4 weeks of use and this was concomitant with a reduction in symptoms associated with the infection (Imase et al. 2007; Francavilla et al. 2007, unpublished data). Further, dietary supplementation with L. reuteri during and after the period of H. pylori eradication therapy has also been shown to reduce the side effects of this therapy without affecting the degree of eradication (Lionetti et al., 2007). It is also feasible, through the inhibitory action of L. reuteri on H. pylori, that pre-exposure to L. reuteri may weaken H. pylori and make it more susceptible to antibiotic attack during eradication.
However, an earlier pilot study was not been able to demonstrate a reduction in gastric inflammation caused by H. pylori. This pilot study was performed with L. reuteri ATCC 55730 that has since been found to lack anti-inflammatory activity in in vitro screens. Recent selection of natural, human L. reuteri strains has identified a specific strain with strong anti-inflammatory properties in vitro (Lin et al, 2007 and submitted 2007). A combination of this strain, together with the earlier proven L. reuteri strain, is expected to lead to both a reduction of H. pylori load as well as a reduction in the gastric inflammation related to the pathogen.
| Condition | Intervention |
|---|---|
|
Helicobacter Pylori Infection |
Dietary Supplement: L. reuteri DSM 17938 and ATCC PTA 6475 Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri |
- to decrease H. pylori gastric load [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Primary Outcome Measures:
Decrease H. pylori gastric load by histology after 28 days compared to placebo and by 13C-UBT compared to placebo.
- To decrease dyspeptic symptoms [ Time Frame: 28 days ] [ Designated as safety issue: No ]To decrease dyspeptic symptoms before, during and after eradication therapy as assessed by a gastro-intestinal symptom rating scale
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 'L. reuteri DSM 17938 and ATCC PTA 6475
L. reuteri will be delivered at a dose of 1x108 CFU of each strain of L. reuteri giving a final dose of L. reuteri of 2x108 CFU. One dose is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day.
|
Dietary Supplement: L. reuteri DSM 17938 and ATCC PTA 6475
L. reuteri dose of 1x108 CFU.
Other Name: Probiotic mixture
|
|
Placebo Comparator: Placebo
Placebo
|
Other: Placebo
Placebo
Other Name: Placebo identical to active
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- 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| Contact: Ruggiero Francavilla, MD, PhD | +390805592063 ext 2847 | rfrancavilla@libero.it |
| Italy | |
| Unit of Gastroenterology | Recruiting |
| Bari, Italy, 70100 | |
| Contact: Beatrice Principi, MD +390805592869 | |
| Principal Investigator: | Principi Beatrice, MD | University of Bari |
More Information
Publications:
| Responsible Party: | Ruggiero Francavilla, MD, PhD, University of Bari |
| ClinicalTrials.gov Identifier: | NCT01115296 History of Changes |
| Other Study ID Numbers: | HP-Progastria |
| Study First Received: | April 28, 2010 |
| Last Updated: | August 16, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Bari:
|
Helicobacter Pylori gastritis Probiotics Lactobacillus Reuteri |
Additional relevant MeSH terms:
|
Helicobacter Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 16, 2013