NCT01456728

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

1.5 years

First QC Date

October 7, 2011

Last Update Submit

September 7, 2013

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pyloriProgastriaLactobacillus reuteriomeprazoletriple therapyprobiotic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

    1 year

  • Number of patients with amelioration of gastrointestinal symptoms in H. pylori-infected subjects treated with ProGastria compared to placebo.

    1 year

  • Confirmation that L. reuteri +omeprazole could improve eradication rates of H. pylori using triple therapy

    1 year

Study Arms (2)

Progastria

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

ProgastriaDIETARY_SUPPLEMENT

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.

Progastria
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology and Hepatology, St Marina University Hospital

Varna, Bulgaria, 9010, Bulgaria

Location

Study Officials

  • Iskren Kotzev, MSc

    Head, Clinik of Gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Iskren Kotzev MD, PhD, MSc

Study Record Dates

First Submitted

October 7, 2011

First Posted

October 21, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2012

Study Completion

September 1, 2013

Last Updated

September 10, 2013

Record last verified: 2013-09

Locations

BU(1)