Lactobacillus Reuteri ProGastria in Helicobacter Pylori-infected Adult Subjects on Proton Pump Inhibitors

Efficacy of Dietary Supplementation With Lactobacillus Reuteri ProGastria in Helicobacter Pylori-infected Adult Subjects Treated Only With Proton Pump Inhibitors

The purpose of the study is to confirm that simultaneous use of L. reuteri ProGastria and omeprazole for 28 days can eradicate H. pylori in humans in the absence of antibiotics.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Dietary supplement: Progastria; Dietary supplement: Placebo

Detailed Description

Helicobacter pylori colonises an estimated 50% of the world´s population. Despite clear clinical guidelines on the treatment of this infection 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. A good alternative is to use probiotics.

Lactic acid bacteria and in particular lactobacilli have been studied for their effects in humans infected with H. pylori with some success in reducing the infection load. 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. 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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Varna, Bulgaria, 9010
    • Department of Gastroenterology and Hepatology, St Marina University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infection with H. pylori defined using the 13C-urea breath 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Progastria; One chewable tablet of the study product is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day together with omeprazole 2x20mg. The study product and omeprazole will be taken daily for 28 consecutive days.	Dietary supplement: Progastria; All subjects will receive 2 x 20 mg omeprazole per day for 28 days. L. reuteri ProGastria will be delivered at a dose of 1x108 CFU of 2 strains of L. reuteri giving a final dose of L. reuteri of 2x108 CFU. One chewable tablet is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day. This dose of L. reuteri has been shown to be effective in a series of conditions earlier, including inhibition of H. pylori in humans, and is considered the optimal dose. The study products will be taken daily for 28 consecutive days.
PLACEBO_COMPARATOR: Placebo; The placebo will have identical appearance and taste with the study product only lacking the bacteria. All subjects from this group will receive 2 x 20 mg omeprazole per day and Placebo 1 chewable tablet per day for 28 days.	Dietary supplement: Placebo; The placebo will have identical in appearance and taste with the active study product only lacking the bacteria. It will be prescribed the same way as ProGastria: omeprazole 2x20mg and Placebo 1 tablet per day for 28 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased number of H. pylori positive subjects treated with L. reuteri-ProGastria for 28 days who are negative for H. pylori after the treatment compared to placebo	Increase in the number of subjects with treatment success after 28 days of treatment with omeprazole + L. reuteri ProGastria compared to those given omeprazole + placebo will prove treatment success defined as the absence of H. pylori infection on Day 29. This is measured as a significant reduction in gastrointestinal symptoms (according to a validated GSRS score) and a negative stool antigen test for H. pylori infection.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased number of subjects from the ProGastria group compared to the placebo group with a maintained absence of H.pylori infection up to 2 months after completed treatment	This outcome measure will be proven when there is evidence of fewer patients in the L. reuteri ProGastria treatment success group with demonstrated presence of H. pylori infection, measured as UBT on Day 90 compared to the placebo treatment success group.	1 year
Number of patients with amelioration of gastrointestinal symptoms in H. pylori-infected subjects treated with ProGastria compared to placebo.	This is achieved by following reduced gastrointestinal symptom scores using GSRS validated scoring system at days 14, 28 and 90 in L. reuteri ProGastria treated subjects compared to placebo.	1 year
Confirmation that L. reuteri +omeprazole could improve eradication rates of H. pylori using triple therapy	This measure will be done by assesing the absence of H. pylori infection on Day 90 measured as a negative outcome in UBT in the L. reuteri ProGastria treatment failure group compared to the placebo treatment failure group	1 year

Collaborators and Investigators

• Sponsor: St Marina University Hospital, Varna, Bulgaria
• Investigators: Principal Investigator: Iskren Kotzev, MSc, Head, Clinik of Gastroenterology

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: October 7, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (ESTIMATE): October 21, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 10, 2013
• Last Update Submitted That Met QC Criteria: September 7, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Helicobacter pylori; probiotic; triple therapy; omeprazole; Lactobacillus reuteri; Progastria
• Other Study ID Numbers: 34/30.06.2011