Helicobacter Pylori InfectionPhase 4NCT01969331
Efficacy and Safety of Probiotic Treatment as a Supportive Therapy in Eradication of H. Pylori
A Phase 4 study testing Normia in people with Helicobacter Pylori Infection, run by Goran Hauser at 1 site in Croatia.
Trial summary
The aim of the study is to establish efficacy and safety of Normia® probiotic, used as an add-on therapy in treatment of H. Pylori infection with the standard triple therapy approach. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Normia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 804 participants
- Where
- 1 siteCroatia
- Study dates
- Dec 2008to Dec 2010
- Phase
- Phase 4
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed H. Pylori infection.
- Otherwise healthy subjects taking H. pylori eradication therapy.
- Age above 16 years.
- Male and female subjects.
- Subject who provided written informed consent prior to undergoing any study procedure.
Who cannot join
- Pregnancy or lactation.
- Severe diseases such as malignant diseases, severe renal/liver impairment, HIV infection etc.
- Chronic diseases such as diabetes mellitus, hypertension, epilepsy or atherosclerosis which are under treatment and well regulated are not an exclusion criterion.
- Subject who is not mentally capable of adhering to the protocol.
- Drug addiction or alcoholism.
- Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.
- Subjects participating in any other clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional, Prospective, Multi-center, Double-blind, Placebo Controlled Postmarketing Study to Evaluate Efficacy and Safety of Normia® Probiotic Treatment as a Supportive Therapy in Eradication of H. Pylori
The aim of the study is to establish efficacy and safety of Normia® probiotic, used as an add-on therapy in treatment of H. Pylori infection with the standard triple therapy approach.
The primary objective in the study is determination of efficacy of Normia® probiotic as a supportive therapy in achieving a higher percentage of eradication of H. Pylori.
The secondary objectives are to assess:
- Safety profile of Normia® probiotic in everyday use, e.g. reduction in number of side-effects and better compliance to the eradication therapy
- Safety and efficacy of Normia® probiotic in different demographic subgroups
Read the detailed description
Gastroenterologists and general practitioners have increasingly more possibilities of prescribing probiotic preparations as the only or (more often) adjuvant therapy in certain indications. A significant step forward was made in the current report of the European Helicobacter Study Group ,which states that "Certain probiotics and prebiotics show promising results as an adjuvant treatment in reducing side effects". At this stage,probiotics are classified as Grade D recommendation. That is precisely why the investigators believe that clinical studies are necessary in order for such effects to be objectively proven in a clinical setting.
The investigators decided to conduct a clinical trial based on a clearly defined and sufficiently frequent indication,with a preparation of known probiotic composition that is easily available on the market, and in a real setting where such approach is bound to show both advantages and disadvantages.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Normia, Placebo
- Keywords
- Gastritis, Helicobacter pylori
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NormiaDietary supplement
Also called Lactobacillus rhamnosus GG, LGG® and Bifidobacterium, BB-12®
One capsule twice a day/14 days
PlaceboDietary supplement
maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171) Placebo as an addition to standard H. Pylori eradication therapy 7 days of initial therapy (2 antibiotics + PPI), followed by 21 days of PPI only therapy.
Two weeks after the end of PPI therapy subjects are seen at the follow up visit. Receives: Dietary Supplement: Placebo |
| Normia | Active comparator | Lactobacillus rhamnosus GG, LGG® and Bifidobacterium, BB-12® Normia® probiotic as an addition to standard H. Pylori eradication therapy 7 days of initial therapy (2 antibiotics + PPI), followed by 21 days of PPI only therapy. One capsule twice per day/14 days Two weeks after the end of PPI therapy subjects are seen at the follow up visit. Receives: Dietary Supplement: Normia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eradication of H.Pylori infection with Normia® probiotic as a additional therapy to standard triple therapy regimen
Duration of participation in the study will depend on the duration of therapy prescribed by the attending physician. The exact type of the basic (triple) therapy prescribed to each subject is at the discretion of the physician.
Assuming standard therapy regimes for this indication, the shortest possible participation in the study will be as follows:
- 7 days of initial triple therapy, followed by
- 21 days of PPI therapy only, followed by
- 14 days +/- 2 days to the follow up visit. Therefore, study participation will take between 40 and 44 days.
Measured: 40-44 days
Secondary outcomes (1)
Reducing the number of adverse events for H. pylori eradication triple therapy using Normia® probiotic as a supportive therapy
Subjects will receive therapy considered to be a "golden standard" for this indication (triple therapy eradication protocol). Subjects receiving Placebo will be receiving standard triple therapy as well.
Measured: 40-44 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startDec 2008
- Primary completionAug 2010
- Study completionDec 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goran Hauser
- Sponsor type
- University, hospital or other
- Collaborators
- Jadran Galenski laboratorij d.d.Rijeka
- Responsible party
- Sponsor-investigator, Goran Hauser, University Hospital Rijeka
- Investigators
- Goran Hauser, MD,PhD, Principal investigator, UH Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969331
- Sponsor's protocol ID
- JGL/02/09
- Status last verified
- Oct 2013
- First submitted
- 9 Oct 2013
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Prospective, Multi-center, Double-blind, Placebo Controlled Postmarketing Study to Evaluate Efficacy and Safety of Normia® Probiotic Treatment as a Supportive Therapy in Eradication of H. Pylori
- ClinicalTrials.gov ID
- NCT01969331
- Acronym / sponsor ID
- JGL/02/09
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Gastritis, Helicobacter pylori
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- Goran HauserUniversity, hospital or other
- Collaborators
- Jadran Galenski laboratorij d.d.Rijeka
- Study start
- Dec 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Oct 2013 (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 aim of the study is to establish efficacy and safety of Normia® probiotic, used as an add-on therapy in treatment of H. Pylori infection with the standard triple therapy approach.
The primary objective in the study is determination of efficacy of Normia® probiotic as a supportive therapy in achieving a higher percentage of eradication of H. Pylori.
The secondary objectives are to assess:
- Safety profile of Normia® probiotic in everyday use, e.g. reduction in number of side-effects and better compliance to the eradication therapy
- Safety and efficacy of Normia® probiotic in different demographic subgroups
Detailed description
Gastroenterologists and general practitioners have increasingly more possibilities of prescribing probiotic preparations as the only or (more often) adjuvant therapy in certain indications. A significant step forward was made in the current report of the European Helicobacter Study Group ,which states that "Certain probiotics and prebiotics show promising results as an adjuvant treatment in reducing side effects". At this stage,probiotics are classified as Grade D recommendation. That is precisely why the investigators believe that clinical studies are necessary in order for such effects to be objectively proven in a clinical setting.
The investigators decided to conduct a clinical trial based on a clearly defined and sufficiently frequent indication,with a preparation of known probiotic composition that is easily available on the market, and in a real setting where such approach is bound to show both advantages and disadvantages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebomaltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171) Placebo as an addition to standard H. Pylori eradication therapy 7 days of initial therapy (2 antibiotics + PPI), followed by 21 days of PPI only therapy. Two weeks after the end of PPI therapy subjects are seen at the follow up visit. |
| Normia | Active comparator | Dietary Supplement: NormiaLactobacillus rhamnosus GG, LGG® and Bifidobacterium, BB-12® Normia® probiotic as an addition to standard H. Pylori eradication therapy 7 days of initial therapy (2 antibiotics + PPI), followed by 21 days of PPI only therapy. One capsule twice per day/14 days Two weeks after the end of PPI therapy subjects are seen at the follow up visit. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed H. Pylori infection.
- Otherwise healthy subjects taking H. pylori eradication therapy.
- Age above 16 years.
- Male and female subjects.
- Subject who provided written informed consent prior to undergoing any study procedure.
Key exclusion criteria (7 listed)
- Pregnancy or lactation.
- Severe diseases such as malignant diseases, severe renal/liver impairment, HIV infection etc.
- Chronic diseases such as diabetes mellitus, hypertension, epilepsy or atherosclerosis which are under treatment and well regulated are not an exclusion criterion.
- Subject who is not mentally capable of adhering to the protocol.
- Drug addiction or alcoholism.
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 |
|---|---|---|
| NormiaAlso: Lactobacillus rhamnosus GG, LGG® and Bifidobacterium, BB-12®One capsule twice a day/14 days | Dietary supplement | Normia |
| Placebomaltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171) | Dietary supplement | Placebo |
Primary outcome
Percentage of eradication of H.Pylori infection with Normia® probiotic as a additional therapy to standard triple therapy regimen
Time frame: 40-44 days
Duration of participation in the study will depend on the duration of therapy prescribed by the attending physician. The exact type of the basic (triple) therapy prescribed to each subject is at the discretion of the physician. Assuming standard therapy regimes for this indication, the shortest possible participation in the study will be as follows: * 7 days of initial triple therapy, followed by * 21 days of PPI therapy only, followed by * 14 days +/- 2 days to the follow up visit. Therefore, study participation will take between 40 and 44 days.
1 secondary outcome
Reducing the number of adverse events for H. pylori eradication triple therapy using Normia® probiotic as a supportive therapy
Time frame: 40-44 days
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 25 Oct 2013.
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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.
Goran Hauser, MD,PhD principal investigator
UH Rijeka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normia in people with Helicobacter Pylori Infection, run by Goran Hauser at 1 site in Croatia.
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 5 inclusion and 7 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 25 Oct 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 Croatia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Percentage of eradication of H.Pylori infection with Normia® probiotic as a additional therapy to standard triple therapy regimen (time frame: 40-44 days). 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 25 Oct 2013.