ArticlePloS one2014
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.
Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- Clinical Evidence on the Health Benefits and Safety of Probiotic Lacticaseibacillus rhamnosus: A Systematic Review.Probiotics and antimicrobial proteins · 2026Pooled it
- Early use of probiotics might prevent antibiotic-associated diarrhea in elderly (>65 years): a systematic review and meta-analysis.BMC geriatrics · 2022Pooled it
- Pooled it
- Safety ofNutrients · 2026Trial
- The Assessment of Multidimensional Clinical, Biological and Patient-Reported Outcomes to Evaluate the Efficacy of Add-OnNutrients · 2026Trial
- Probiotics use for antibiotic-associated diarrhea: a pragmatic participatory evaluation in nursing homes.BMC gastroenterology · 2020Trial
- Long-term safety assessment in children who received hydrolyzed protein formulas with Lactobacillus rhamnosus GG: a 5-year follow-up.European journal of pediatrics · 2017Trial
- Functional dynamics of the gut microbiome in elderly people during probiotic consumption.mBio · 2015Trial
- Lactobacilli Mitigate Gut Inflammation by Modulating T-Helper/T-Regulatory Cells and Suppressing Signaling Pathways in Food-Derived Models.Probiotics and antimicrobial proteins · 2026Review
- Lactobacillus rhamnosus GG cell-free supernatant as a novel anti-cancer adjuvant.Journal of translational medicine · 2023Article
- The gut microbiota is an emerging target for improving brain health during ageing.Gut microbiome (Cambridge, England) · 2023Article
- Ameliorative effect of Lactobacillus rhamnosus GG on acetaminophen-induced hepatotoxicity via PKC/Nrf2/PGC-1α pathway.Journal, genetic engineering & biotechnology · 2022Article
- Biotechnological Processes Simulating the Natural Fermentation Process of Bee Bread and Therapeutic Properties-An Overview.Frontiers in nutrition · 2022Review
- Transcriptome analysis of Lactobacillus rhamnosus GG strain treated with prebiotic - bovine lactoferrin under a cold environment.Journal of food and drug analysis · 2021Article
- Gut Microbiota, Probiotic Interventions, and Cognitive Function in the Elderly: A Review of Current Knowledge.Nutrients · 2021Review
- Probiotics for the Prevention of Acute Respiratory-Tract Infections in Older People: Systematic Review.Healthcare (Basel, Switzerland) · 2021Review
- Short-Term Tolerability, Safety, and Gut Microbial Composition Responses to a Multi-Strain Probiotic Supplement: An Open-Label Study in Healthy Adults.Integrative medicine (Encinitas, Calif.) · 2021Article
- Effect of Simulated Gastrointestinal Tract Conditions on Survivability of Probiotic Bacteria Present in Commercial Preparations.International journal of environmental research and public health · 2021Article
- Article
- Tendencies and Challenges in Worldwide Scientific Research on Probiotics.Probiotics and antimicrobial proteins · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundAlthough 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.
objectivesThe 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.
methodsFifteen 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.
resultsThere 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.
conclusionsLactobacillus rhamnosus GG ATCC 53103 is safe and well tolerated in healthy adults aged 65 years and older.
trial registrationClinicalTrials.gov NCT 01274598.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.