Helicobacter InfectionsGastrusNCT02645201
The Effect of Probiotic Combination on Helicobacter Pylori Infection in Children
A study testing Gastrus in people with Helicobacter Infections, run by University Medical Centre Ljubljana at 5 sites in 5 countries.
Trial summary
The combination of two Lactubacillus reuteri strains, ATC 55730 and ATCC PTA 6457 are marketed as GASTRUS® and has been proposed as better option in increasing Helicobacter pylori eradication rate compared to the single strain ATC 55730, due to additional anti-inflammatory properties of the second strain. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Helicobacter Infections
- What is being tested?
- Gastrus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Jan 2016to 18 Aug 2017
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Either sex age between 5 (>15 kg) - 18 years.
- Confirmed H. pylori infection (two out of four invasive methods positive (rapid urease test/histology/culture/PCR test) with positive culture and susceptibility testing for clarithromycin and metronidazole).
- Able to be informed (patient/parents) of the nature of the study and willing to give written informed consent (consent from the parents must be obtained before any study-related procedures are conducted and assent of the child if older than 10 years).
- Treatment naive children with H. pylori infection.
Who cannot join
- Significant acute or chronic GE disease (IBD, symptomatic coeliac disease…)
- Known allergies to used antibiotics, proton pump inhibitors or probiotics
- Having received treatment with antibiotics or bismuth compounds during the previous 30 days before endoscopy.
- Having received proton pump inhibitors during the previous two weeks.
- Having received probiotic therapy during the previous 14 days.
- Being infected with a strain resistant to clarithromycin and metronidazole (double resistant)
- Severe acquired or primary immunodeficiency.
- Children with gastric or duodenal peptic ulcer disease
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Effect of a Probiotic Combination (Gastrus®) on Adverse Effects of Therapy and on Eradication Rate of Helicobacter Pylori Infection in Children
The combination of two Lactubacillus reuteri strains, ATC 55730 and ATCC PTA 6457 are marketed as GASTRUS® and has been proposed as better option in increasing Helicobacter pylori eradication rate compared to the single strain ATC 55730, due to additional anti-inflammatory properties of the second strain.
Objectives of the study are to determine whether adding probiotic combination (GASTRUS®) to an anti- Helicobacter pylori regimen decreases adverse events and increases the eradication rate of Helicobacter pylori in the pediatric population infected with Helicobacter pylori bacteria.
Read the detailed description
This is a 10 week, randomized, double blind, placebo controlled, multicenter study to evaluate the efficacy of GASTRUS® on the frequency of adverse events and eradication rate of H. pylori infection in children.
Subjects: Children aged 5 (>15 kg) -18 years, diagnosed with H. pylori infection during upper endoscopy with at least two validated tests, who meet all inclusion and exclusion criteria listed below. Subjects who are RUT (Rapid Urease Test) positive on the day of endoscopy will be offered to participate in the study, which includes 3 visits. They will be given information about the study and a 1-week diary to be filled out before visit 1. The properly filled diary will be considered as the screening tool to include the patients into the study and will be also considered as part of the study. At visit 1 written informed consent must be obtained from the caregivers and also from participants above 10 years of age. At each visit, physical examination will be performed as well as symptom assessment and diary evaluation. Only patients who have a positive culture for H. pylori and antibiotic susceptibility testing with no double resistance, and have filled in the diary will be enrolled. Patients will receive a prescription for triple therapy: omeprazole, amoxicillin and metronidazole / clarithromycin for 14 days depending on the antibiotic susceptibility. The dose regimens will be determined according to the weight of the child. The children will be randomized to receive chewable tablets containing 4x108 CFU of GASTRUS® or placebo of similar appearance and taste. Active and placebo tablets will be supplied. Subjects will take 1 tablet twice a day for 21 days. Diary 2 - will be dispensed (with instructions) and filled for 21 days until visit 2. Visit 2 will take place 21+/- 3 days after visit 1. At this visit a physical exam will be performed and diary 2 will be collected. Diary 3 will be reminded to be filled out one week before visit 3 which will be planned 8 weeks after visit 2 +/- 5 days. At visit 3, diary 3 will be collected. 13C-urea breath test or monoclonal stool antigen test will be performed to assess the H. pylori status after eradication treatment. In order to ensure that the children will fill their diaries, the parents will be phoned one week before visit 2 and 3.
Our study population will be children from all over Europe and Israel diagnosed with H. pylori infection with at least two recommended diagnostic methods. The investigators will complete documents considered for enrolment.
The sample size was calculated assuming that adverse effects will develop in 30% of treated children, aiming to detect difference of 20% based on a 0.80 power to detect statistically significant difference; therefore the recruitment will continue until 118 subjects are randomized into the 2 groups (test and placebo) of at least 59 children each. The estimated time to finish the study is 2-3 years.
- Conditions
- Helicobacter Infections
- Being tested
- Gastrus, Placebo
- Keywords
- probiotic
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrusDietary supplement
Also called Lactobacillus reuteri (ATC 55730 and ATCC PTA 6457)
to compare Gastrus 4x108 tbl twice a day to placebo tbl
PlaceboOther
Also called Placebo pills
to compare Gastrus 4x108 tbl twice a day to placebo tbl
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Children in probiotic group will receive chewable tablets containing 4x108 CFU of Gastrus. Subjects will take 1 tablet twice a day for 21 days Receives: Dietary Supplement: Gastrus |
| Placebo | Placebo comparator | Children in placebo group will receive placebo tablets of similar appearance and taste as Gastrus tablets. Subjects will take 1 placebo tablet twice a day for 21 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare changes of frequency and type of adverse events (abdominal pain, duration of pain, nausea, heartburn, vomiting, taste disturbance, stool consistency) in probiotic and placebo arm at different time frames
symptom diary (abdominal pain, duration of pain, nausea, heartburn, vomiting, taste disturbance, stool consistency-frequency)
Measured: at visit 1, visit 2 (after 3 weeks), visit 3 (after 8 weeks)
Secondary outcomes (1)
to compare the number of patients with succesful eradication of Helicobacter pylori infection in probiotic and placebo arm
13C-urea breath test or monoclonal stool antigen test
Measured: 8-12 weeks after eradication therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion18 Aug 2017 (estimated)
- Study completion18 Aug 2017 (estimated)
Why it stopped: The research protocol was completely changed.
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 InfectionsStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tadej Battelino, University Medical Centre Ljubljana
- Investigators
- Matjaz Homan, MD PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645201
- Sponsor's protocol ID
- Gastrus01
- Acronym
- Gastrus
- Status last verified
- Aug 2017
- First submitted
- 12 Dec 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Francavilla R, Polimeno L, Demichina A, Maurogiovanni G, Principi B, Scaccianoce G, Ierardi E, Russo F, Riezzo G, Di Leo A, Cavallo L, Francavilla A, Versalovic J. Lactobacillus reuteri strain combination in Helicobacter pylori infection: a randomized, double-blind, placebo-controlled study. J Clin Gastroenterol. 2014 May-Jun;48(5):407-13. doi: 10.1097/MCG.0000000000000007.
PubMed 24296423
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Probiotic Combination (Gastrus®) on Adverse Effects of Therapy and on Eradication Rate of Helicobacter Pylori Infection in Children
- ClinicalTrials.gov ID
- NCT02645201
- Acronym / sponsor ID
- Gastrus / Gastrus01
- Conditions
- Helicobacter Infections
- Keywords
- probiotic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The research protocol was completely changed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 18 Aug 2017 (estimated)
- Study completion
- 18 Aug 2017 (estimated)
- First posted
- 1 Jan 2016 (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 combination of two Lactubacillus reuteri strains, ATC 55730 and ATCC PTA 6457 are marketed as GASTRUS® and has been proposed as better option in increasing Helicobacter pylori eradication rate compared to the single strain ATC 55730, due to additional anti-inflammatory properties of the second strain.
Objectives of the study are to determine whether adding probiotic combination (GASTRUS®) to an anti- Helicobacter pylori regimen decreases adverse events and increases the eradication rate of Helicobacter pylori in the pediatric population infected with Helicobacter pylori bacteria.
Detailed description
This is a 10 week, randomized, double blind, placebo controlled, multicenter study to evaluate the efficacy of GASTRUS® on the frequency of adverse events and eradication rate of H. pylori infection in children.
Subjects: Children aged 5 (>15 kg) -18 years, diagnosed with H. pylori infection during upper endoscopy with at least two validated tests, who meet all inclusion and exclusion criteria listed below. Subjects who are RUT (Rapid Urease Test) positive on the day of endoscopy will be offered to participate in the study, which includes 3 visits. They will be given information about the study and a 1-week diary to be filled out before visit 1. The properly filled diary will be considered as the screening tool to include the patients into the study and will be also considered as part of the study. At visit 1 written informed consent must be obtained from the caregivers and also from participants above 10 years of age. At each visit, physical examination will be performed as well as symptom assessment and diary evaluation. Only patients who have a positive culture for H. pylori and antibiotic susceptibility testing with no double resistance, and have filled in the diary will be enrolled. Patients will receive a prescription for triple therapy: omeprazole, amoxicillin and metronidazole / clarithromycin for 14 days depending on the antibiotic susceptibility. The dose regimens will be determined according to the weight of the child. The children will be randomized to receive chewable tablets containing 4x108 CFU of GASTRUS® or placebo of similar appearance and taste. Active and placebo tablets will be supplied. Subjects will take 1 tablet twice a day for 21 days. Diary 2 - will be dispensed (with instructions) and filled for 21 days until visit 2. Visit 2 will take place 21+/- 3 days after visit 1. At this visit a physical exam will be performed and diary 2 will be collected. Diary 3 will be reminded to be filled out one week before visit 3 which will be planned 8 weeks after visit 2 +/- 5 days. At visit 3, diary 3 will be collected. 13C-urea breath test or monoclonal stool antigen test will be performed to assess the H. pylori status after eradication treatment. In order to ensure that the children will fill their diaries, the parents will be phoned one week before visit 2 and 3.
Our study population will be children from all over Europe and Israel diagnosed with H. pylori infection with at least two recommended diagnostic methods. The investigators will complete documents considered for enrolment.
The sample size was calculated assuming that adverse effects will develop in 30% of treated children, aiming to detect difference of 20% based on a 0.80 power to detect statistically significant difference; therefore the recruitment will continue until 118 subjects are randomized into the 2 groups (test and placebo) of at least 59 children each. The estimated time to finish the study is 2-3 years.
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 |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: GastrusChildren in probiotic group will receive chewable tablets containing 4x108 CFU of Gastrus. Subjects will take 1 tablet twice a day for 21 days |
| Placebo | Placebo comparator | Other: PlaceboChildren in placebo group will receive placebo tablets of similar appearance and taste as Gastrus tablets. Subjects will take 1 placebo tablet twice a day for 21 days |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Either sex age between 5 (>15 kg) - 18 years.
- Confirmed H. pylori infection (two out of four invasive methods positive (rapid urease test/histology/culture/PCR test) with positive culture and susceptibility testing for clarithromycin and metronidazole).
- Able to be informed (patient/parents) of the nature of the study and willing to give written informed consent (consent from the parents must be obtained before any study-related procedures are conducted and assent of the child if older than 10 years).
- Treatment naive children with H. pylori infection.
Key exclusion criteria (8 listed)
- Significant acute or chronic GE disease (IBD, symptomatic coeliac disease…)
- Known allergies to used antibiotics, proton pump inhibitors or probiotics
- Having received treatment with antibiotics or bismuth compounds during the previous 30 days before endoscopy.
- Having received proton pump inhibitors during the previous two weeks.
- Having received probiotic therapy during the previous 14 days.
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 |
|---|---|---|
| GastrusAlso: Lactobacillus reuteri (ATC 55730 and ATCC PTA 6457)to compare Gastrus 4x108 tbl twice a day to placebo tbl | Dietary supplement | Probiotic |
| PlaceboAlso: Placebo pillsto compare Gastrus 4x108 tbl twice a day to placebo tbl | Other | Placebo |
Primary outcome
to compare changes of frequency and type of adverse events (abdominal pain, duration of pain, nausea, heartburn, vomiting, taste disturbance, stool consistency) in probiotic and placebo arm at different time frames
Time frame: at visit 1, visit 2 (after 3 weeks), visit 3 (after 8 weeks)
symptom diary (abdominal pain, duration of pain, nausea, heartburn, vomiting, taste disturbance, stool consistency-frequency)
1 secondary outcome
to compare the number of patients with succesful eradication of Helicobacter pylori infection in probiotic and placebo arm
Time frame: 8-12 weeks after eradication therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Results publication: PubMed 24296423Francavilla R, Polimeno L, Demichina A, Maurogiovanni G, Principi B, Scaccianoce G, Ierardi E, Russo F, Riezzo G, Di Leo A, Cavallo L, Francavilla A, Versalovic J. Lactobacillus reuteri strain combination in Helicobacter pylori infection: a randomized, double-blind, placebo-controlled study. J Clin Gastroenterol. 2014 May-Jun;48(5):407-13. doi: 10.1097/MCG.0000000000000007.
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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.
Matjaz Homan, MD PhD principal investigator
University Medical Centre Ljubljana
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastrus in people with Helicobacter Infections, run by University Medical Centre Ljubljana at 5 sites in 5 countries.
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 22 Aug 2017. 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 Belgium, Croatia, Germany, Israel, Slovenia. 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 was withdrawn before enrolling participants, so there are no results.
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?
to compare changes of frequency and type of adverse events (abdominal pain, duration of pain, nausea, heartburn, vomiting, taste disturbance, stool consistency) in probiotic and placebo arm at different time frames (time frame: at visit 1, visit 2 (after 3 weeks), visit 3 (after 8 weeks)). 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 NCT02645201, 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 22 Aug 2017.