Helicobacter Pylori InfectionPhase 3NCT01456728
Lactobacillus Reuteri ProGastria in Helicobacter Pylori-infected Adult Subjects on Proton Pump Inhibitors
A Phase 3 study testing Progastria in people with Helicobacter Pylori Infection, run by St Marina University Hospital, Varna, Bulgaria at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Progastria
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteBulgaria
- Study dates
- Jan 2011to Sep 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Department of Gastroenterology and Hepatology, St Marina University Hospital
Varna, Bulgaria, 9010
About this study
Official title: 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.
Read the 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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Progastria, Placebo
- Keywords
- Helicobacter pylori, Progastria, Lactobacillus reuteri, omeprazole, triple therapy, probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgastriaDietary supplement
All subjects will receive 2 x 20 mg omeprazole per day for 28 days.
- 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.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Marina University Hospital, Varna, Bulgaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iskren Kotzev, St Marina University Hospital, Varna, Bulgaria
- Investigators
- Iskren Kotzev, MSc, Principal investigator, Head, Clinik of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456728
- Sponsor's protocol ID
- 34/30.06.2011
- Status last verified
- Sep 2013
- First submitted
- 7 Oct 2011
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dietary Supplementation With Lactobacillus Reuteri ProGastria in Helicobacter Pylori-infected Adult Subjects Treated Only With Proton Pump Inhibitors
- ClinicalTrials.gov ID
- NCT01456728
- Acronym / sponsor ID
- 34/30.06.2011
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Progastria, Lactobacillus reuteri, omeprazole, triple therapy, probiotic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- St Marina University Hospital, Varna, BulgariaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progastria | Experimental | Dietary Supplement: ProgastriaOne 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Duodenal or gastric ulcer
- MALT lymphoma
- Gastric resection (at any time)
- First level relatives of gastric cancer patients
- Absence of GI symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProgastriaAll 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. | Dietary supplement | Progastria |
| PlaceboThe 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 | Dietary supplement | Placebo |
Primary outcome
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
Time frame: 1 year
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.
3 secondary outcomes
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
Time frame: 1 year
Number of patients with amelioration of gastrointestinal symptoms in H. pylori-infected subjects treated with ProGastria compared to placebo.
Time frame: 1 year
Confirmation that L. reuteri +omeprazole could improve eradication rates of H. pylori using triple therapy
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iskren Kotzev, MSc principal investigator
Head, Clinik of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Progastria in people with Helicobacter Pylori Infection, run by St Marina University Hospital, Varna, Bulgaria at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.