Recovery of Lactobacillus Reuteri ATCC PTA 4659NCT01033539
To Demonstrate That Lactobacillus Reuteri ATCC PTA 4659 Survives Passage Through the Gastrointestinal Tract of Humans
A study testing Probiotic strain ATCC PTA 4659 in people with Recovery of Lactobacillus Reuteri ATCC PTA 4659 and The Safety of Lactobacillus Reuteri ATCC PTA 4659, run by Good Food Practice, Sweden at 1 site in Sweden.
Trial summary
The purpose of this study is to determine the effects of a sachet containing Lactobacillus Reuteri ATCC PTA 4659 on the recovery of live Lactobacillus reuteri in fecal samples after 7, 14 and 28 days supplementation as well as 14 days wash out compared to the same sachet without the probiotic bacteria as placebo… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Recovery of Lactobacillus Reuteri ATCC PTA 4659, The Safety of Lactobacillus Reuteri ATCC PTA 4659
- What is being tested?
- Probiotic strain ATCC PTA 4659
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2009to Aug 2011
- 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
- Males and females
- Age 18-65 years
- BMI 19-33
- Hb 120 g/women 130 g/l for men
- Healthy assessed by screening tests and physical examination
- Signed informed consent and bio bank consent
Who cannot join
- Participation in a clinical study within 90 days prior screening use of antibiotics 2 weeks before baseline
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effects of a sachet containing Lactobacillus Reuteri ATCC PTA 4659 on the recovery of live Lactobacillus reuteri in fecal samples after 7, 14 and 28 days supplementation as well as 14 days wash out compared to the same sachet without the probiotic bacteria as placebo control.
Read the detailed description
This study is the first to investigate the relative colonisation of the human GI tract by L Reuteri ATCC PTA 4659. Simple demonstration that they survive passage is the first step in development of potential new probiotics, which is necessary before these strains can be considered for continued testing in probiotic food matrices. The aim of this study will evaluate the safety and tolerability of Lactobacillus Reuteri in healthy adult subjects.
- Conditions
- Recovery of Lactobacillus Reuteri ATCC PTA 4659, The Safety of Lactobacillus Reuteri ATCC PTA 4659
- Being tested
- Probiotic strain ATCC PTA 4659
- Keywords
- Survive, safety, lactobacillus Reuteri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic strain ATCC PTA 4659Other
Also called ATCC PTA 4659
Placebo control containing no probiotic strain of ATCC PTA 4659 High dose of ATCC PTA 4659 1*10 10 CFU/bag Low dose of ATCC PTA 4659 1*10 8 CFU/bag
| Study group | Role | What they receive |
|---|---|---|
| Placebo control | Active comparator | Placebo control without probiotics ATCC PTA 4659 Receives: Other: Probiotic strain ATCC PTA 4659 |
| ATCC PTA 4659 Low dose | Active comparator | Not described Receives: Other: Probiotic strain ATCC PTA 4659 |
| ATCC PTA 4659 high dose | Active comparator | Not described Receives: Other: Probiotic strain ATCC PTA 4659 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change form baseline to day 28 on treatment in level of live Lactobacillus Reuteri ATC PTA 4659 in faecal material.
Measured: Nov 2009-April2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2010
- Study completionAug 2011
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 Recovery of Lactobacillus Reuteri ATCC PTA 4659Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Good Food Practice, Sweden
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Birgitta E Sundberg, PhD, Principal investigator, Good Food Practice, Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033539
- Sponsor's protocol ID
- CSP U-08-008 BSS
- Status last verified
- Mar 2012
- First submitted
- 15 Dec 2009
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Sendelius M, Axelsson J, Liu P, Roos S. Genomic, phenotypic, and clinical safety of Limosilactobacillus reuteri ATCC PTA 4659. J Ind Microbiol Biotechnol. 2023 Feb 17;50(1):kuad041. doi: 10.1093/jimb/kuad041.
PubMed 37974056
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Demonstrate That Lactobacillus Reuteri ATCC PTA 4659 Survives Passage Through the Gastrointestinal Tract of Humans
- ClinicalTrials.gov ID
- NCT01033539
- Acronym / sponsor ID
- CSP U-08-008 BSS
- Conditions
- Recovery of Lactobacillus Reuteri ATCC PTA 4659, The Safety of Lactobacillus Reuteri ATCC PTA 4659
- Keywords
- Survive, safety, lactobacillus Reuteri
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Good Food Practice, SwedenIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 16 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.
The purpose of this study is to determine the effects of a sachet containing Lactobacillus Reuteri ATCC PTA 4659 on the recovery of live Lactobacillus reuteri in fecal samples after 7, 14 and 28 days supplementation as well as 14 days wash out compared to the same sachet without the probiotic bacteria as placebo control.
Detailed description
This study is the first to investigate the relative colonisation of the human GI tract by L Reuteri ATCC PTA 4659. Simple demonstration that they survive passage is the first step in development of potential new probiotics, which is necessary before these strains can be considered for continued testing in probiotic food matrices. The aim of this study will evaluate the safety and tolerability of Lactobacillus Reuteri in healthy adult subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo control | Active comparator | Other: Probiotic strain ATCC PTA 4659Placebo control without probiotics ATCC PTA 4659 |
| ATCC PTA 4659 Low dose | Active comparator | Other: Probiotic strain ATCC PTA 4659 |
| ATCC PTA 4659 high dose | Active comparator | Other: Probiotic strain ATCC PTA 4659 |
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
- BMI 19-33
- Hb 120 g/women 130 g/l for men
- Healthy assessed by screening tests and physical examination
Key exclusion criteria (2 listed)
- Participation in a clinical study within 90 days prior screening use of antibiotics 2 weeks before baseline
- Pregnant or lactating
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 |
|---|---|---|
| Probiotic strain ATCC PTA 4659Also: ATCC PTA 4659Placebo control containing no probiotic strain of ATCC PTA 4659 High dose of ATCC PTA 4659 1*10 10 CFU/bag Low dose of ATCC PTA 4659 1*10 8 CFU/bag | Other | ATCC PTA 4659 Low dose, ATCC PTA 4659 high dose, Placebo control |
Primary outcome
Change form baseline to day 28 on treatment in level of live Lactobacillus Reuteri ATC PTA 4659 in faecal material.
Time frame: Nov 2009-April2010
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 29 Mar 2012.
- Derived from this study: PubMed 37974056Sendelius M, Axelsson J, Liu P, Roos S. Genomic, phenotypic, and clinical safety of Limosilactobacillus reuteri ATCC PTA 4659. J Ind Microbiol Biotechnol. 2023 Feb 17;50(1):kuad041. doi: 10.1093/jimb/kuad041.
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.
Birgitta E Sundberg, PhD principal investigator
Good Food Practice, Uppsala, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic strain ATCC PTA 4659 in people with Recovery of Lactobacillus Reuteri ATCC PTA 4659 and The Safety of Lactobacillus Reuteri ATCC PTA 4659, 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 2 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 29 Mar 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. 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?
Change form baseline to day 28 on treatment in level of live Lactobacillus Reuteri ATC PTA 4659 in faecal material. (time frame: Nov 2009-April2010). 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 NCT01033539, 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 29 Mar 2012.