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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo control | Active Comparator | Placebo control without probiotics ATCC PTA 4659 |
|
| ATCC PTA 4659 Low dose | Active Comparator |
| |
| ATCC PTA 4659 high dose | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic strain ATCC PTA 4659 | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change form baseline to day 28 on treatment in level of live Lactobacillus Reuteri ATC PTA 4659 in faecal material. | Nov 2009-April2010 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birgitta E Sundberg, PhD | Good Food Practice, Uppsala, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Food Practice | Uppsala | Uppsala County | 751 83 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37974056 | Derived | 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. |
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