SafetyPhase 1/2BSSIINCT01568567
Study to Demonstrate the Safety of a Novel Powder Formulation of Lactobacilli in Adults
A Phase 1/2 study testing Lactobacillus Reuteri DSM 17938 in people with Safety, run by Good Food Practice, Sweden at 1 site in Sweden.
Trial summary
Lactobacilli are commensal bacteria common to the gut of all mammals studied and traditionally associated with foods are considered safe.The established safe use on a diversity of foods and supplement products worldwide supports this conclusion. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety
- What is being tested?
- Lactobacillus Reuteri DSM 17938
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2012to Jun 2012
- Phase
- Phase 1/2
- 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
- Males and females
- Age 18-65 years at visit 1
- BMI 19-29
- Hb ≥ 120 g/l for women and ≥ 130 g/l for men
- Healthy as assessed by the screening laboratory tests and blood pressure determined by the MD
- Signed informed consent and biobank consent
Who cannot join
- Participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
- Use of oral antibiotics or probiotics during 2 weeks prior to visit 1. Other probiotics other than the study products are not allowed during the study period.
- Pregnant or lactating or wish to become pregnant during the period of the study.
- Lack of suitability for participation in the trial, for any reason, as judged by the personnel at Good Food Practice AB.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Demonstrate That a Novel Powder Formulation of Lactobacillus Reuteri DSM 17938 is Safe in Adults, a Randomized, Placebo Controlled Double-blind Study
Lactobacilli are commensal bacteria common to the gut of all mammals studied and traditionally associated with foods are considered safe.The established safe use on a diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract of humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants as well as adults.
Although the tolerability of DSM 17938 in a tablet formulation has earlier been established, it is desirable to repeat the assessment in this novel formulation.
- Conditions
- Safety
- Being tested
- Lactobacillus Reuteri DSM 17938
- Keywords
- safety, tolerance, lactobacillus Reuteri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus Reuteri DSM 17938Dietary supplement
One stick pack in the morning and one stick pack afternoon/evening for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Double dose | Active comparator | One stick pack with active ingredients contains 1.0 g contains 75% GOS (galactooligosaccharide), 25% L-Rhamnose, 1x108 live bacteria (CFU) Lactobacillus reuteri and silicon dioxide Receives: Dietary Supplement: Lactobacillus Reuteri DSM 17938 |
| Single dose | Active comparator | One stick pack with active ingredients contains 1.0 g contains 75% GOS (galactooligosaccharide), 25% L-Rhamnose, 1x108 live bacteria (CFU) Lactobacillus reuteri and silicon dioxide Receives: Dietary Supplement: Lactobacillus Reuteri DSM 17938 |
| Placebo | Placebo comparator | One stick pack with placebo contains 1.0 g maltodextrin and silicon dioxide Receives: Dietary Supplement: Lactobacillus Reuteri DSM 17938 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by blood chemistry parameters
To assess the safety of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation.
Measured: 28 days
Tolerability measured by blood chemistry parameters
To assess tolerability of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Good Food Practice, Sweden
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioGaia AB
- Responsible party
- Sponsor
- Investigators
- Johan Olsson, PhD, Principal investigator, KPL Good Food Practice AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568567
- Sponsor's protocol ID
- CSP U-11-008
- Other IDs
- CSUB0031
- Acronym
- BSSII
- Status last verified
- Jul 2012
- First submitted
- 28 Mar 2012
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Demonstrate That a Novel Powder Formulation of Lactobacillus Reuteri DSM 17938 is Safe in Adults, a Randomized, Placebo Controlled Double-blind Study
- ClinicalTrials.gov ID
- NCT01568567
- Acronym / sponsor ID
- BSSII / CSP U-11-008
- Conditions
- Safety
- Keywords
- safety, tolerance, lactobacillus Reuteri
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Good Food Practice, SwedenIndustry (pharma, biotech, devices)
- Collaborators
- BioGaia AB
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Apr 2012 (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.
Lactobacilli are commensal bacteria common to the gut of all mammals studied and traditionally associated with foods are considered safe.The established safe use on a diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract of humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants as well as adults.
Although the tolerability of DSM 17938 in a tablet formulation has earlier been established, it is desirable to repeat the assessment in this novel formulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double dose | Active comparator | Dietary Supplement: Lactobacillus Reuteri DSM 17938One stick pack with active ingredients contains 1.0 g contains 75% GOS (galactooligosaccharide), 25% L-Rhamnose, 1x108 live bacteria (CFU) Lactobacillus reuteri and silicon dioxide |
| Single dose | Active comparator | Dietary Supplement: Lactobacillus Reuteri DSM 17938One stick pack with active ingredients contains 1.0 g contains 75% GOS (galactooligosaccharide), 25% L-Rhamnose, 1x108 live bacteria (CFU) Lactobacillus reuteri and silicon dioxide |
| Placebo | Placebo comparator | Dietary Supplement: Lactobacillus Reuteri DSM 17938One stick pack with placebo contains 1.0 g maltodextrin and silicon dioxide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females
- Age 18-65 years at visit 1
- BMI 19-29
- Hb ≥ 120 g/l for women and ≥ 130 g/l for men
- Healthy as assessed by the screening laboratory tests and blood pressure determined by the MD
Key exclusion criteria (4 listed)
- Participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
- Use of oral antibiotics or probiotics during 2 weeks prior to visit 1. Other probiotics other than the study products are not allowed during the study period.
- Pregnant or lactating or wish to become pregnant during the period of the study.
- Lack of suitability for participation in the trial, for any reason, as judged by the personnel at Good Food Practice AB.
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 Reuteri DSM 17938One stick pack in the morning and one stick pack afternoon/evening for 28 days. | Dietary supplement | Double dose, Placebo, Single dose |
Primary outcome
Safety measured by blood chemistry parameters
Time frame: 28 days
To assess the safety of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation.
Tolerability measured by blood chemistry parameters
Time frame: 28 days
To assess tolerability of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation.
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 4 Jul 2012.
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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.
Johan Olsson, PhD principal investigator
KPL Good Food Practice AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lactobacillus Reuteri DSM 17938 in people with Safety, run by Good Food Practice, Sweden at 1 site in Sweden.
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 4 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 4 Jul 2012. 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 Sweden. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety measured by blood chemistry parameters (time frame: 28 days). The study lists 2 primary outcomes in all. 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 4 Jul 2012.