Control of Helicobacter Pylori Infection by Probiotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01115296
Recruitment Status : Unknown
Verified August 2012 by Ruggiero Francavilla, University of Bari.
Recruitment status was:  Recruiting
First Posted : May 4, 2010
Last Update Posted : August 17, 2012
Information provided by (Responsible Party):
Ruggiero Francavilla, University of Bari

Brief Summary:

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was concomitant with a reduction in symptoms associated with the infection (Imase et al. 2007; Francavilla et al. 2007, unpublished data).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 or disease Intervention/treatment Phase
Helicobacter Pylori Infection Dietary Supplement: L. reuteri DSM 17938 and ATCC PTA 6475 Other: Placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri
Study Start Date : January 2010
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Other: Placebo
Other Name: Placebo identical to active

Primary Outcome Measures :
  1. to decrease H. pylori gastric load [ Time Frame: 28 days ]

    Primary Outcome Measures:

    Decrease H. pylori gastric load by histology after 28 days compared to placebo and by 13C-UBT compared to placebo.

Secondary Outcome Measures :
  1. To decrease dyspeptic symptoms [ Time Frame: 28 days ]
    To decrease dyspeptic symptoms before, during and after eradication therapy as assessed by a gastro-intestinal symptom rating scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01115296

Contact: Ruggiero Francavilla, MD, PhD +390805592063 ext 2847

Unit of Gastroenterology Recruiting
Bari, Italy, 70100
Contact: Beatrice Principi, MD    +390805592869      
Sponsors and Collaborators
University of Bari
Principal Investigator: Principi Beatrice, MD University of Bari

Responsible Party: Ruggiero Francavilla, MD, PhD, University of Bari Identifier: NCT01115296     History of Changes
Other Study ID Numbers: HP-Progastria
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: August 17, 2012
Last Verified: August 2012

Keywords provided by Ruggiero Francavilla, University of Bari:
Helicobacter Pylori
Lactobacillus Reuteri

Additional relevant MeSH terms:
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections