Helicobacter Pylori InfectionNCT04178187
The Role of Probiotics in the Eradication of Helicobacter Pylori
A study testing Caps Lactolevure in people with Helicobacter Pylori Infection, run by Evangelismos Hospital at 5 sites in Greece.
Trial summary
All patients will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two groups. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Caps Lactolevure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 660 participants
- Where
- 5 sitesGreece
- Study dates
- 2 Oct 2019to 31 Dec 2021
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Established Helicobacter Pylori Infection
Who cannot join
- Pregnancy
- Lactate
- Previous eradication therapy for HP.
- Course of antibiotics and/or probiotics one month prior to stydy entry
- Course of PPI's, H2- antagonst and antacids two weeks prior to study entry
- Known allergy to antibiotics that will be used in study
- Coronary disease, heart failure,malignancy,thyroid disease, pulmonary disease or other serious disease as per medical judgment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Greece5 sites
Evangelismos Hospital
Athens, Attica, 10676
NIMTS Hospital
Athens, 11521
Iatriko Palaiou Falirou
Palaió Fáliro, 17562
University General Hospital of Thessaloniki AHEPA
Thessaloniki, 54636
General Hospital of Thessaloniki Ippokratio
Thessaloniki, 54642
About this study
All patients will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two groups. The first group will receive one capsule of probiotics x2 two hours before or after meal for 15 days and the second group placebo (capsule with same composition and colour with probiotic) x2, two hours before or after meal for 15 days as well.
The probiotic (Lactolevure, Uni-Pharma, Athens) contains four probiotic strains known for their effectivness and safety, Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium Lactis BB-12 (1.75 BU/capsule), Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and Lactobacillus Plantarum (0.5 BU/capsule).
Read the detailed description
Patients with H.Pylori infection establised after a uper GI endoscopy and gastric biopsy will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two groups. The first group will receive one capsule of probiotics x2 two hours before or after meal for 15 days and the second group placebo (capsule with same composition and colour with probiotic) x2, two hours before or after meal for 15 days as well.
The probiotic contains four probiotic strains known for their effectivness and safety, Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium Lactis BB-12 (1.75 BU/capsule), Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and Lactobacillus Plantarum (0.5 BU/capsule).
Patients will report in a specific questionnare the presence or absence of symptoms suggestive of side effects associated with the Abx administered (i.e flatulance, abdominal pain, diarrhoea, regurgitation, vomiting).
All patints will be subjected to urea breath test one month after the completion of treatment in order to verify HP eradication.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Caps Lactolevure, Caps Placebo
- Keywords
- Helicobacter Pylori, Probiotics, Eradication treatment of H.Pylori, Antibiotics, Proton pump inhibitors, Saccharomyces boulardii, Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus plantarum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caps LactolevureDrug
Also called Probiotics
One group will receive Caps Lactolevure x2 and the other group Caps Placebo x2.
Caps PlaceboDrug
Caps Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lactolevure | Active comparator | Patients will receive quadruple eradication therapy for Helicobacter Pylori infection with Amoxicillin, Clarithromycin, Metronidazole, Omeprazole and Probiotics Receives: Drug: Caps Lactolevure |
| Placebo | Placebo comparator | Patients will receive quadruple eradication therapy for Helicobacter Pylori infection with Amoxicillin, Clarithromycin, Metronidazole, Omeprazole and Placebo Receives: Drug: Caps Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of antibiotic side effects
Primary prevention of Abx side effects as assessed by a questionnaire including all possible side effects (i.e. vomiting, diarrhea, flatulence etc) on a ten point Likert scale.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start2 Oct 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelismos Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikos Viazis, Evangelismos Hospital
- Investigators
- Nikos Viazis, Dr, Principal investigator, Evangelismos HospitalKaterina Kotzampassi, MD, Principal investigator, AHEPA University HospitalOlga Giouleme, MD, Principal investigator, General Hospital Of Thessaloniki IppokratioPeriklis Apostolopoulos, MD, Principal investigator, NIMTS HospitalSotirios Georgopoulos, MD, Principal investigator, Iatriko Palaiou Falirou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178187
- Sponsor's protocol ID
- 444/23/07/2019
- Status last verified
- Mar 2022
- First submitted
- 8 Nov 2019
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kotzampassi K, Stavrou G, Damoraki G, Georgitsi M, Basdanis G, Tsaousi G, Giamarellos-Bourboulis EJ. A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study. World J Surg. 2015 Nov;39(11):2776-83. doi: 10.1007/s00268-015-3071-z.
PubMed 25894405
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Probiotics in the Eradication of Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT04178187
- Acronym / sponsor ID
- 444/23/07/2019
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter Pylori, Probiotics, Eradication treatment of H.Pylori, Antibiotics, Proton pump inhibitors, Saccharomyces boulardii, Bifidobacterium lactis, Lactobacillus acidophilus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Evangelismos HospitalUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Nov 2019 (actual)
- 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.
All patients will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two groups. The first group will receive one capsule of probiotics x2 two hours before or after meal for 15 days and the second group placebo (capsule with same composition and colour with probiotic) x2, two hours before or after meal for 15 days as well.
The probiotic (Lactolevure, Uni-Pharma, Athens) contains four probiotic strains known for their effectivness and safety, Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium Lactis BB-12 (1.75 BU/capsule), Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and Lactobacillus Plantarum (0.5 BU/capsule).
Detailed description
Patients with H.Pylori infection establised after a uper GI endoscopy and gastric biopsy will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two groups. The first group will receive one capsule of probiotics x2 two hours before or after meal for 15 days and the second group placebo (capsule with same composition and colour with probiotic) x2, two hours before or after meal for 15 days as well.
The probiotic contains four probiotic strains known for their effectivness and safety, Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium Lactis BB-12 (1.75 BU/capsule), Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and Lactobacillus Plantarum (0.5 BU/capsule).
Patients will report in a specific questionnare the presence or absence of symptoms suggestive of side effects associated with the Abx administered (i.e flatulance, abdominal pain, diarrhoea, regurgitation, vomiting).
All patints will be subjected to urea breath test one month after the completion of treatment in order to verify HP eradication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactolevure | Active comparator | Drug: Caps LactolevurePatients will receive quadruple eradication therapy for Helicobacter Pylori infection with Amoxicillin, Clarithromycin, Metronidazole, Omeprazole and Probiotics |
| Placebo | Placebo comparator | Drug: Caps PlaceboPatients will receive quadruple eradication therapy for Helicobacter Pylori infection with Amoxicillin, Clarithromycin, Metronidazole, Omeprazole and Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Established Helicobacter Pylori Infection
Key exclusion criteria (7 listed)
- Pregnancy
- Lactate
- Previous eradication therapy for HP.
- Course of antibiotics and/or probiotics one month prior to stydy entry
- Course of PPI's, H2- antagonst and antacids two weeks prior to study entry
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 |
|---|---|---|
| Caps LactolevureAlso: ProbioticsOne group will receive Caps Lactolevure x2 and the other group Caps Placebo x2. | Drug | Lactolevure |
| Caps PlaceboCaps Placebo | Drug | Placebo |
Primary outcome
Prevention of antibiotic side effects
Time frame: Through study completion, an average of 1 year
Primary prevention of Abx side effects as assessed by a questionnaire including all possible side effects (i.e. vomiting, diarrhea, flatulence etc) on a ten point Likert scale.
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 Mar 2022.
- Results publication: PubMed 25894405Kotzampassi K, Stavrou G, Damoraki G, Georgitsi M, Basdanis G, Tsaousi G, Giamarellos-Bourboulis EJ. A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study. World J Surg. 2015 Nov;39(11):2776-83. doi: 10.1007/s00268-015-3071-z.
- Individual participant dataSharing planned: No
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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.
Nikos Viazis, Dr principal investigator
Evangelismos Hospital
Katerina Kotzampassi, MD principal investigator
AHEPA University Hospital
Olga Giouleme, MD principal investigator
General Hospital Of Thessaloniki Ippokratio
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caps Lactolevure in people with Helicobacter Pylori Infection, run by Evangelismos Hospital at 5 sites in Greece.
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 1 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 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Greece. 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?
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?
Prevention of antibiotic side effects (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178187, which also lists 1 linked publication.
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 Mar 2022.