Helicobacter Pylori InfectionNCT01593592
Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients
A study testing Lactobacillus reuteri, Omeprazole and Amoxicillin in people with Helicobacter Pylori Infection, run by Zagazig University at 1 site in Egypt.
Trial summary
Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Lactobacillus reuteri, Omeprazole and Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-60 years
- Any sex
- Confirmed H. Pylori infection defined by pathological lesions and either histopathological confirmation of the organism, rapid urease test or H. Pylori antigen in stool
- Good mentality to understand aim, benefits and steps of the study
- Assumed availability during the study period
- Written informed consent
Who cannot join
- Patients with chronic diseases e.g. diabetes, renal failure, cirrhosis…etc.
- Patients with malignancy.
- Patients with gall bladder disorders.
- Patients with peptic ulcer.
- Patients with prior upper GIT surgery.
- Patients with probiotics therapy in the last one month.
Show all 9Show fewer
- Patients with triple therapy, antibiotics, proton pump inhibitors and H2 receptor blockers therapy within one month.
- Patients with known allergy to the used medications
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients: a Double Blind Placebo Controlled Randomized Clinical Trial
Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.
Read the detailed description
Helicobacter pylori (H. Pylori) infection is a wide spread disease and is endemic in many countries including Egypt with a wide range of morbidity; that requires appropriate antimicrobial therapy . However, worldwide the eradication rate following the standard triple therapy is declining and this may necessitates introduction of new antimicrobial agents . On the sight of bearing in vivo and in vitro activity against H. Pylori, the use of different strains of probiotics in treatment of H. Pylori may be thus justifiable, Lactobacillus reuteri (L. reuteri) which through different mechanisms including production of reuterin have anti H.pylori activity have been tried in improving the eradication rates of H.pylori with contradictory results . This study is conducted to test the assumption that addition of L. reuteri to the standard triple therapy in treatment of H. Pylori improves the eradication rates and clinical aspects in H. Pylori infection.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Lactobacillus reuteri, Placebo, Omeprazole, Amoxicillin, Clarithromycin
- Keywords
- Helicobacter pylori, Lactobacillus reuteri, dyspeptic patients, eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteriDietary supplement
Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.
PlaceboDietary supplement
Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.
OmeprazoleDrug
All patients will receive omeprazole 20 mg b.i.d for 2 week
AmoxicillinDrug
amoxicillin 1000 mg b.i.d for 2 weeks
ClarithromycinDrug
clarithromycin 500mg b.i.d for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus reuteri group | Experimental | The active group that will receive the standard triple therapy and Lactobacillus reuteri Receives: Dietary Supplement: Lactobacillus reuteri; Drug: Omeprazole; Drug: Amoxicillin; Drug: Clarithromycin |
| Control group | Placebo comparator | The control group that will receive the standard triple therapy and placebo Receives: Dietary Supplement: Placebo; Drug: Omeprazole; Drug: Amoxicillin; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of H Pylori Infection 4 Weeks After Completion of Therapy
- pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy.
Measured: 4 weeks therapy
Secondary outcomes (2)
Severe Adverse Effects to the Used Medications and Dietary Supplements.
Measured: 4 weeks
The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.
Severe adverse effects to the used medications and dietary supplements, these may expose the participants to major morbidity and may change the outcomes in them.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Collaborators
- BioGaia AB
- Responsible party
- Principal investigator, Moahmed Hassan Emara, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593592
- Sponsor's protocol ID
- IRB#:395/29-4-2012
- Other IDs
- IRB#:395/29-4-2012
- Status last verified
- Jul 2015
- First submitted
- 5 May 2012
- Last updated
- 17 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients: a Double Blind Placebo Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01593592
- Acronym / sponsor ID
- IRB#:395/29-4-2012
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Lactobacillus reuteri, dyspeptic patients, eradication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Collaborators
- BioGaia AB
- Study start
- Jun 2012
- Primary completion
- Jan 2013 (actual)
- First posted
- 8 May 2012 (estimated)
- Results
- Posted 17 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.
Detailed description
Helicobacter pylori (H. Pylori) infection is a wide spread disease and is endemic in many countries including Egypt with a wide range of morbidity; that requires appropriate antimicrobial therapy . However, worldwide the eradication rate following the standard triple therapy is declining and this may necessitates introduction of new antimicrobial agents . On the sight of bearing in vivo and in vitro activity against H. Pylori, the use of different strains of probiotics in treatment of H. Pylori may be thus justifiable, Lactobacillus reuteri (L. reuteri) which through different mechanisms including production of reuterin have anti H.pylori activity have been tried in improving the eradication rates of H.pylori with contradictory results . This study is conducted to test the assumption that addition of L. reuteri to the standard triple therapy in treatment of H. Pylori improves the eradication rates and clinical aspects in H. Pylori infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus reuteri group | Experimental | Dietary Supplement: Lactobacillus reuteri, Drug: Omeprazole, Drug: Amoxicillin, Drug: ClarithromycinThe active group that will receive the standard triple therapy and Lactobacillus reuteri |
| Control group | Placebo comparator | Dietary Supplement: Placebo, Drug: Omeprazole, Drug: Amoxicillin, Drug: ClarithromycinThe control group that will receive the standard triple therapy and placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 18-60 years
- Any sex
- Confirmed H. Pylori infection defined by pathological lesions and either histopathological confirmation of the organism, rapid urease test or H. Pylori antigen in stool
- Good mentality to understand aim, benefits and steps of the study
- Assumed availability during the study period
Key exclusion criteria (9 listed)
- -
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 |
|---|---|---|
| Lactobacillus reuteriWill receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks. | Dietary supplement | Lactobacillus reuteri group |
| PlaceboWill receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks. | Dietary supplement | Control group |
| OmeprazoleAll patients will receive omeprazole 20 mg b.i.d for 2 week | Drug | Control group, Lactobacillus reuteri group |
| Amoxicillinamoxicillin 1000 mg b.i.d for 2 weeks | Drug | Control group, Lactobacillus reuteri group |
| Clarithromycinclarithromycin 500mg b.i.d for 2 weeks | Drug | Control group, Lactobacillus reuteri group |
Primary outcome
Eradication of H Pylori Infection 4 Weeks After Completion of Therapy
Time frame: 4 weeks therapy
H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy.
2 secondary outcomes
Severe Adverse Effects to the Used Medications and Dietary Supplements.
Time frame: 4 weeks
The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study location HospitalLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus reuteri, Omeprazole and Amoxicillin in people with Helicobacter Pylori Infection, run by Zagazig University at 1 site in Egypt.
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 17 Aug 2015. 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 Egypt. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Eradication of H Pylori Infection 4 Weeks After Completion of Therapy (time frame: 4 weeks therapy). 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 17 Aug 2015.