No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a phase I open label study to assess safety, tolerability and cytokine responses.
<h4>Background</h4>Although Lactobacillus rhamnosus GG ATCC 53103 (LGG) has been consumed by 2 to 5 million people daily since the mid 1990s, there are few clinical trials describing potential harms of LGG, particularly in the elderly.<h4>Objectives</h4>The primary objective...
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2014-01-01
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| Series: | PLoS ONE |
| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0113456&type=printable |
| _version_ | 1826587337987981312 |
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| author | Patricia L Hibberd Lauren Kleimola Anne-Maria Fiorino Christine Botelho Miriam Haverkamp Irina Andreyeva Debra Poutsiaka Claire Fraser Gloria Solano-Aguilar David R Snydman |
| author_facet | Patricia L Hibberd Lauren Kleimola Anne-Maria Fiorino Christine Botelho Miriam Haverkamp Irina Andreyeva Debra Poutsiaka Claire Fraser Gloria Solano-Aguilar David R Snydman |
| author_sort | Patricia L Hibberd |
| collection | DOAJ |
| description | <h4>Background</h4>Although Lactobacillus rhamnosus GG ATCC 53103 (LGG) has been consumed by 2 to 5 million people daily since the mid 1990s, there are few clinical trials describing potential harms of LGG, particularly in the elderly.<h4>Objectives</h4>The primary objective of this open label clinical trial is to assess the safety and tolerability of 1×1010 colony forming units (CFU) of LGG administered orally twice daily to elderly volunteers for 28 days. The secondary objectives were to evaluate the effects of LGG on the gastrointestinal microbiome, host immune response and plasma cytokines.<h4>Methods</h4>Fifteen elderly volunteers, aged 66-80 years received LGG capsules containing 1×1010 CFU, twice daily for 28 days and were followed through day 56. Volunteers completed a daily diary, a telephone call on study days 3, 7 and 14 and study visits in the Clinical Research Center at baseline, day 28 and day 56 to determine whether adverse events had occurred. Assessments included prompted and open-ended questions.<h4>Results</h4>There were no serious adverse events. The 15 volunteers had a total of 47 events (range 1-7 per volunteer), 39 (83%) of which were rated as mild and 40% of which were considered related to consuming LGG. Thirty-one (70%) of the events were expected, prompted symptoms while 16 were unexpected events. The most common adverse events were gastrointestinal (bloating, gas, and nausea), 27 rated as mild and 3 rated as moderate. In the exploratory analysis, the pro-inflammatory cytokine interleukin 8 decreased during LGG consumption, returning towards baseline one month after discontinuing LGG (p = 0.038) while there was no difference in other pro- or anti-inflammatory plasma cytokines.<h4>Conclusions</h4>Lactobacillus rhamnosus GG ATCC 53103 is safe and well tolerated in healthy adults aged 65 years and older.<h4>Trial registration</h4>ClinicalTrials.gov NCT 01274598. |
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| format | Article |
| id | doaj.art-26704da20cad4a91b463a9838ca19013 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2025-03-14T16:23:50Z |
| publishDate | 2014-01-01 |
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| spelling | doaj.art-26704da20cad4a91b463a9838ca190132025-02-22T05:32:06ZengPublic Library of Science (PLoS)PLoS ONE1932-62032014-01-01912e11345610.1371/journal.pone.0113456No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a phase I open label study to assess safety, tolerability and cytokine responses.Patricia L HibberdLauren KleimolaAnne-Maria FiorinoChristine BotelhoMiriam HaverkampIrina AndreyevaDebra PoutsiakaClaire FraserGloria Solano-AguilarDavid R Snydman<h4>Background</h4>Although Lactobacillus rhamnosus GG ATCC 53103 (LGG) has been consumed by 2 to 5 million people daily since the mid 1990s, there are few clinical trials describing potential harms of LGG, particularly in the elderly.<h4>Objectives</h4>The primary objective of this open label clinical trial is to assess the safety and tolerability of 1×1010 colony forming units (CFU) of LGG administered orally twice daily to elderly volunteers for 28 days. The secondary objectives were to evaluate the effects of LGG on the gastrointestinal microbiome, host immune response and plasma cytokines.<h4>Methods</h4>Fifteen elderly volunteers, aged 66-80 years received LGG capsules containing 1×1010 CFU, twice daily for 28 days and were followed through day 56. Volunteers completed a daily diary, a telephone call on study days 3, 7 and 14 and study visits in the Clinical Research Center at baseline, day 28 and day 56 to determine whether adverse events had occurred. Assessments included prompted and open-ended questions.<h4>Results</h4>There were no serious adverse events. The 15 volunteers had a total of 47 events (range 1-7 per volunteer), 39 (83%) of which were rated as mild and 40% of which were considered related to consuming LGG. Thirty-one (70%) of the events were expected, prompted symptoms while 16 were unexpected events. The most common adverse events were gastrointestinal (bloating, gas, and nausea), 27 rated as mild and 3 rated as moderate. In the exploratory analysis, the pro-inflammatory cytokine interleukin 8 decreased during LGG consumption, returning towards baseline one month after discontinuing LGG (p = 0.038) while there was no difference in other pro- or anti-inflammatory plasma cytokines.<h4>Conclusions</h4>Lactobacillus rhamnosus GG ATCC 53103 is safe and well tolerated in healthy adults aged 65 years and older.<h4>Trial registration</h4>ClinicalTrials.gov NCT 01274598.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0113456&type=printable |
| spellingShingle | Patricia L Hibberd Lauren Kleimola Anne-Maria Fiorino Christine Botelho Miriam Haverkamp Irina Andreyeva Debra Poutsiaka Claire Fraser Gloria Solano-Aguilar David R Snydman No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a phase I open label study to assess safety, tolerability and cytokine responses. PLoS ONE |
| title | No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a phase I open label study to assess safety, tolerability and cytokine responses. |
| title_full | No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a phase I open label study to assess safety, tolerability and cytokine responses. |
| title_fullStr | No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a phase I open label study to assess safety, tolerability and cytokine responses. |
| title_full_unstemmed | No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a phase I open label study to assess safety, tolerability and cytokine responses. |
| title_short | No evidence of harms of probiotic Lactobacillus rhamnosus GG ATCC 53103 in healthy elderly-a phase I open label study to assess safety, tolerability and cytokine responses. |
| title_sort | no evidence of harms of probiotic lactobacillus rhamnosus gg atcc 53103 in healthy elderly a phase i open label study to assess safety tolerability and cytokine responses |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0113456&type=printable |
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