Control of Helicobacter Pylori Infection by Probiotics

NCT01115296 | Unknown DMC

• 1 other identifier: HP-Progastria
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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was concomitant with a reduction in symptoms associated with the infection (Imase et al. 2007; Francavilla et al. 2007, unpublished data).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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori; gastritis; Probiotics; Lactobacillus Reuteri

Outcome Measures

Primary Outcomes (1)

• to decrease H. pylori gastric load

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

  28 days

Secondary Outcomes (1)

• To decrease dyspeptic symptoms

  28 days

Study Arms (2)

'L. reuteri DSM 17938 and ATCC PTA 6475

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

L. reuteri DSM 17938 and ATCC PTA 6475 DIETARY_SUPPLEMENT

L. reuteri dose of 1x108 CFU.

Also known as: Probiotic mixture

'L. reuteri DSM 17938 and ATCC PTA 6475

Placebo OTHER

Placebo

Also known as: Placebo identical to active

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Duodenal or gastric ulcer
• MALT lymphoma
• Gastric resection (at any time)
• First level relatives of gastric cancer patients
• Absence of GI symptoms
• 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

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Unit of Gastroenterology

Bari, Italy, 70100, Italy

RECRUITING

Related Publications (1)

• Francavilla R, Lionetti E, Castellaneta SP, Magista AM, Maurogiovanni G, Bucci N, De Canio A, Indrio F, Cavallo L, Ierardi E, Miniello VL. Inhibition of Helicobacter pylori infection in humans by Lactobacillus reuteri ATCC 55730 and effect on eradication therapy: a pilot study. Helicobacter. 2008 Apr;13(2):127-34. doi: 10.1111/j.1523-5378.2008.00593.x.

  PMID: 18321302 BACKGROUND

MeSH Terms

Conditions

Gastritis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Principi Beatrice, MD

  University of Bari

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruggiero Francavilla, MD, PhD

CONTACT

+390805592063; rfrancavilla@libero.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: May 4, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 17, 2012

Record last verified: 2012-08

Locations

IT (1)