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.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Lactobacillus rhamnosus GG ATCC 53103 is safe and well tolerated in healthy adults aged 65 years and older.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT 01274598.
authors.affiliation: Division of Global Health, Massachusetts General Hospital for Children, Boston, MA, United States of America.
authors.forename: Patricia L
authors.initials: PL
authors.lastname: Hibberd
authors.affiliation: Division of Global Health, Massachusetts General Hospital for Children, Boston, MA, United States of America.
authors.forename: Lauren
authors.initials: L
authors.lastname: Kleimola
authors.affiliation: Division of Global Health, Massachusetts General Hospital for Children, Boston, MA, United States of America.
authors.forename: Anne-Maria
authors.initials: AM
authors.lastname: Fiorino
authors.affiliation: Division of Global Health, Massachusetts General Hospital for Children, Boston, MA, United States of America.
authors.forename: Christine
authors.initials: C
authors.lastname: Botelho
authors.affiliation: Division of Global Health, Massachusetts General Hospital for Children, Boston, MA, United States of America.
authors.forename: Miriam
authors.initials: M
authors.lastname: Haverkamp
authors.affiliation: Division of Global Health, Massachusetts General Hospital for Children, Boston, MA, United States of America.
authors.forename: Irina
authors.initials: I
authors.lastname: Andreyeva
authors.affiliation: Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center, Boston, MA, United States of America.
authors.forename: Debra
authors.initials: D
authors.lastname: Poutsiaka
authors.affiliation: Institute for Genome Sciences, University of Maryland School of Medicine, Baltimore, MD, United States of America.
authors.forename: Claire
authors.initials: C
authors.lastname: Fraser
authors.affiliation: United States Department of Agriculture, Agricultural Research Service, Beltsville Human Nutrition Research Center, Diet, Genomics, and Immunology Laboratory, Beltsville, MD, United States of America.
authors.forename: Gloria
authors.initials: G
authors.lastname: Solano-Aguilar
authors.affiliation: Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center, Boston, MA, United States of America.
authors.forename: David R
authors.initials: DR
authors.lastname: Snydman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016207:Cytokines / Q000097:blood*; D004355:Drug Stability; D005243:Feces / Q000382:microbiology; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D052201:Lacticaseibacillus rhamnosus; D008297:Male; D010349:Patient Compliance; D019936:Probiotics / Q000009:adverse effects*; D012449:Safety
chemical_list: D016207:Cytokines