Helicobacter Pylori InfectionPhase 4NCT03150394
Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice.
A Phase 4 study testing GASTRUS in people with Helicobacter Pylori Infection, run by Dr. Luis Fernandez at 2 sites in Spain.
Trial summary
Helicobacter pylori is a Gram-negative bacterium with a helical bacillus shape that it's able to penetrate and colonize the stomach mucosal lining by infecting it. The eradication treatment of H. pylori is supported by numerous consensus groups worldwide and it is generally safe and well tolerated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- GASTRUS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesSpain
- Study dates
- 4 Apr 2017to Aug 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients attended at the clinic visit who present a positive diagnosis of H pylori infection using different diagnostic techniques (C13 breath test, histology, urease and / or H pylori antigen in stools).
- Age between 18 and 65 years
Who cannot join
- Patients taking other probiotics 4 weeks prior to study start.
- Patients who have previously received eradicating therapy.
- Patients who are treated with NSAIDs, aspirin or other anti-inflammatory drugs either on an occasional basis (one week prior to the study) or on a chronic basis (3 weeks prior to inclusion).
- Patients who have used oral antibiotics two weeks prior to inclusion.
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Jesus Barrio, PhD contact
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
Luis Fernandez, PhD, +34607537815, luisfernsal@gmail.com
- Recruiting
Hospital Universitario Río Hortega.
Valladolid, 47012
Jesus Barrio, PhD, jbarrioa95@gmail.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice
Helicobacter pylori is a Gram-negative bacterium with a helical bacillus shape that it's able to penetrate and colonize the stomach mucosal lining by infecting it.
The eradication treatment of H. pylori is supported by numerous consensus groups worldwide and it is generally safe and well tolerated. Standard treatment is based on multiple drug regimens. However, its effectiveness has been increasingly compromised due to the emergence of resistant strains, as well as poor adherence to treatment. Therefore, it's proposed a randomized, double-blind, placebo-controlled study whose aims are:
Read more
- Determine whether the combination of two probiotic strains of L reuteri (Gastrus) will improve gastrointestinal symptoms when associated with four-way therapy (of any type).
- Prove whether supplementation with Gastrus (food supplement) versus Placebo is able to reduce the gastrointestinal adverse effects of quadruple eradication therapy.
They will be determined by the GSRS gastrointestinal symptom scale in routine clinical practice.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- GASTRUS, PLACEBO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GASTRUSDietary supplement
Gastrus will be given from the first day of eradication treatment to completion after 30 days of treatment
PLACEBOOther
Placebo will be given from the first day of eradication treatment to completion after 30 days of treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment of quadruple eradication therapy with GASTRUS | Experimental | Not described Receives: Dietary Supplement: GASTRUS |
| Treatment of quadruple eradication therapy with PLACEBO | Placebo comparator | Not described Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global score of gastrointestinal symptoms assessed according the GSRS scale
Measured: 30 days
Secondary outcomes (1)
Score obtained from each individual gastrointestinal symptom evaluated according the GSRS scale. Percentage of patients completing treatment
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start4 Apr 2017
- Primary completionJun 2018 (estimated)
- Study completionAug 2018 (estimated)
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Luis Fernandez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Luis Fernandez, Hospital Clínico Universitario de Valladolid
- Investigators
- Dr. Fernandez Dr. Jesus Barrio, Study director, Managers study
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150394
- Sponsor's protocol ID
- VALACT-2017-01
- Status last verified
- Aug 2017
- First submitted
- 5 May 2017
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice
- ClinicalTrials.gov ID
- NCT03150394
- Acronym / sponsor ID
- VALACT-2017-01
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dr. Luis FernandezUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 12 May 2017 (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.
Helicobacter pylori is a Gram-negative bacterium with a helical bacillus shape that it's able to penetrate and colonize the stomach mucosal lining by infecting it.
The eradication treatment of H. pylori is supported by numerous consensus groups worldwide and it is generally safe and well tolerated. Standard treatment is based on multiple drug regimens. However, its effectiveness has been increasingly compromised due to the emergence of resistant strains, as well as poor adherence to treatment. Therefore, it's proposed a randomized, double-blind, placebo-controlled study whose aims are:
- Determine whether the combination of two probiotic strains of L reuteri (Gastrus) will improve gastrointestinal symptoms when associated with four-way therapy (of any type).
- Prove whether supplementation with Gastrus (food supplement) versus Placebo is able to reduce the gastrointestinal adverse effects of quadruple eradication therapy.
They will be determined by the GSRS gastrointestinal symptom scale in routine clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment of quadruple eradication therapy with GASTRUS | Experimental | Dietary Supplement: GASTRUS |
| Treatment of quadruple eradication therapy with PLACEBO | Placebo comparator | Other: PLACEBO |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients attended at the clinic visit who present a positive diagnosis of H pylori infection using different diagnostic techniques (C13 breath test, histology, urease and / or H pylori antigen in stools).
- Age between 18 and 65 years
Key exclusion criteria (5 listed)
- Patients taking other probiotics 4 weeks prior to study start.
- Patients who have previously received eradicating therapy.
- Patients who are treated with NSAIDs, aspirin or other anti-inflammatory drugs either on an occasional basis (one week prior to the study) or on a chronic basis (3 weeks prior to inclusion).
- Patients who have used oral antibiotics two weeks prior to inclusion.
- Pregnancy
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 |
|---|---|---|
| GASTRUSGastrus will be given from the first day of eradication treatment to completion after 30 days of treatment | Dietary supplement | Treatment of quadruple eradication therapy with GASTRUS |
| PLACEBOPlacebo will be given from the first day of eradication treatment to completion after 30 days of treatment | Other | Treatment of quadruple eradication therapy with PLACEBO |
Primary outcome
Global score of gastrointestinal symptoms assessed according the GSRS scale
Time frame: 30 days
1 secondary outcome
Score obtained from each individual gastrointestinal symptom evaluated according the GSRS scale. Percentage of patients completing treatment
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- 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.
Jesus Barrio, PhD contact
Dr. Fernandez Dr. Jesus Barrio study director
Managers study
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GASTRUS in people with Helicobacter Pylori Infection, run by Dr. Luis Fernandez at 2 sites in Spain.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 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 2 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis Fernandez, PhD (+34607537815, luisfernsal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global score of gastrointestinal symptoms assessed according the GSRS scale (time frame: 30 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 Aug 2017.