Helicobacter Pylori InfectionNCT01028690
Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri
A study testing Lactobacillus reuteri in people with Helicobacter Pylori Infection and Dyspepsia, run by Centro Regional para el Estudio de las Enfermedades Digestivas at 1 site in Mexico.
Trial summary
Helicobacter pylori colonizes approximately to 50% of the world-wide population. There is an exigency to find routes alternating to control the infection with an ample perspective but without the complications of induction of resistance to antibiotics. Supplement dietetic with Lactobacillus reuteri (L. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Dyspepsia
- What is being tested?
- Lactobacillus reuteri
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2009to Jan 2012
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 18 - 65 years
- Infection with H. pylori defined as ∆ > 20 ppm in the UBT test
- Non-ulcer dyspepsia
- No earlier eradication therapy for H. pylori infection
- Written informed consent
- Stated availability throughout the entire study period
- Mental ability to understand and willingness to fulfil all the details of the protocol
Who cannot join
- Duodenal or gastric ulcer
- MALT lymphoma
- Penicillin allergy
- Gastric resection (at any time)
- First level relatives of gastric cancer patients
- Absence of GI symptoms
Show all 10Show fewer
- Use of NSAIDs, aspirin or other anti-inflammatory drugs within 1 week (for occasional use) or 3 weeks (for chronic use) of inclusion
- Use of oral antibiotics and/or PPIs and/or H2-antagonists during the 2 weeks prior to ingestion of the study product
- Pregnancy
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro Regional para el Estudio de las Enfermedades Digestivas, Facultad de Medicina y Hospital Universitario, UANL
Monterrey, Nuevo León, 64460
About this study
Helicobacter pylori colonizes approximately to 50% of the world-wide population.
There is an exigency to find routes alternating to control the infection with an ample perspective but without the complications of induction of resistance to antibiotics. Supplement dietetic with Lactobacillus reuteri (L. reuteri) in humans takes to the colonization of epithelium gastric and this, combined with the observation of which L. reuteri has the capacity to inhibit the growth of H. Pylori and its union to the gastric mucosa, indicates the potential that the native human bacteria control and influence in the colonization in humans.
The acid-lactic bacteria (in particular the lactobacillus) have been studied by their effects in humans infected with H. Pylori with some success to reduce the load of bacteria Studies using supplements with L. reuteri as much in infected symptomatic patients as asymptomatic with H. pylori showed a clear reduction of the load of bacteria after 4 weeks of use and this was concordant with a reduction in the symptoms associated to the infection.
Read the detailed description
The objective of this study is to determine if the dietetic supplementation with a combination of the stock of L. Reuteri (L. reuteri Progastria) is effective to control the load of bacteria and the consequences of the infection in patients infected with H. pylori.
- Conditions
- Helicobacter Pylori Infection, Dyspepsia
- Being tested
- Lactobacillus reuteri, Placebo
- Keywords
- Helicobacter pylori, Eradication therapy, Lactobacillus reuteri, Dyspeptic symptoms
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteriDietary supplement
Also called Progastria
Lactobacillus reuteri is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475; will be delivered at a dose of 1x108 CFU of each strain. One dose is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day. Will be taken daily throughout the entire study, from the day of inclusion to the final analysis at the end of follow-up after eradication therapy. Will be delivered either in a chewable tablet form
PlaceboDietary supplement
Also called bioGaia
placebo
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus reuteri | Active comparator | L. reuteri is one species of lactobacillus that naturally inhabits the gastrointestinal tract of humans Receives: Dietary Supplement: Lactobacillus reuteri |
| placebo | Placebo comparator | Placebo will be delivered in a chewable tablet form (1.5g per dose) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessed decrease H. pylori gastric load by histology after 28 days compared to placebo and assessed by 13C-UBT before and after 28 days use of L. compared to placebo
Measured: 28 days
Secondary outcomes (1)
To decrease dyspeptic symptoms before, during and after eradication therapy as assessed by a gastro-intestinal symptom rating scoring within and between L. reuteri and placebo-supplemented subjects
Measured: 101 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionSep 2011 (estimated)
- Study completionJan 2012 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Regional para el Estudio de las Enfermedades Digestivas
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Investigators
- Francisco J Bosques, MD PhD, Principal investigator, Centro Regional para el Estudio de las Enfermedades Digestivas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028690
- Sponsor's protocol ID
- lactobacilos vs helicobacter
- Status last verified
- Jun 2011
- First submitted
- 7 Dec 2009
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri
- ClinicalTrials.gov ID
- NCT01028690
- Acronym / sponsor ID
- lactobacilos vs helicobacter
- Conditions
- Helicobacter Pylori Infection, Dyspepsia
- Keywords
- Helicobacter pylori, Eradication therapy, Lactobacillus reuteri, Dyspeptic symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Regional para el Estudio de las Enfermedades DigestivasUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- Dec 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 9 Dec 2009 (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.
Helicobacter pylori colonizes approximately to 50% of the world-wide population.
There is an exigency to find routes alternating to control the infection with an ample perspective but without the complications of induction of resistance to antibiotics. Supplement dietetic with Lactobacillus reuteri (L. reuteri) in humans takes to the colonization of epithelium gastric and this, combined with the observation of which L. reuteri has the capacity to inhibit the growth of H. Pylori and its union to the gastric mucosa, indicates the potential that the native human bacteria control and influence in the colonization in humans.
The acid-lactic bacteria (in particular the lactobacillus) have been studied by their effects in humans infected with H. Pylori with some success to reduce the load of bacteria Studies using supplements with L. reuteri as much in infected symptomatic patients as asymptomatic with H. pylori showed a clear reduction of the load of bacteria after 4 weeks of use and this was concordant with a reduction in the symptoms associated to the infection.
Detailed description
The objective of this study is to determine if the dietetic supplementation with a combination of the stock of L. Reuteri (L. reuteri Progastria) is effective to control the load of bacteria and the consequences of the infection in patients infected with H. pylori.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus reuteri | Active comparator | Dietary Supplement: Lactobacillus reuteriL. reuteri is one species of lactobacillus that naturally inhabits the gastrointestinal tract of humans |
| placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo will be delivered in a chewable tablet form (1.5g per dose) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects aged 18 - 65 years
- Infection with H. pylori defined as ∆ > 20 ppm in the UBT test
- Non-ulcer dyspepsia
- No earlier eradication therapy for H. pylori infection
- Written informed consent
Key exclusion criteria (10 listed)
- Duodenal or gastric ulcer
- MALT lymphoma
- Penicillin allergy
- Gastric resection (at any time)
- First level relatives of gastric cancer patients
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 reuteriAlso: ProgastriaLactobacillus reuteri is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475; will be delivered at a dose of 1x108 CFU of each strain. One dose is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day. Will be taken daily throughout the entire study, from the day of inclusion to the final analysis at the end of follow-up after eradication therapy. Will be delivered either in a chewable tablet form | Dietary supplement | Lactobacillus reuteri |
| PlaceboAlso: bioGaiaplacebo | Dietary supplement | placebo |
Primary outcome
Assessed decrease H. pylori gastric load by histology after 28 days compared to placebo and assessed by 13C-UBT before and after 28 days use of L. compared to placebo
Time frame: 28 days
1 secondary outcome
To decrease dyspeptic symptoms before, during and after eradication therapy as assessed by a gastro-intestinal symptom rating scoring within and between L. reuteri and placebo-supplemented subjects
Time frame: 101 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
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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.
Francisco J Bosques, MD PhD principal investigator
Centro Regional para el Estudio de las Enfermedades Digestivas
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 in people with Helicobacter Pylori Infection and Dyspepsia, run by Centro Regional para el Estudio de las Enfermedades Digestivas at 1 site in Mexico.
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 7 inclusion and 10 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 22 Jun 2011. 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 Mexico. 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?
Results are not available in the source record.
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?
Assessed decrease H. pylori gastric load by histology after 28 days compared to placebo and assessed by 13C-UBT before and after 28 days use of L. compared to placebo (time frame: 28 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 22 Jun 2011.