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Table 2 Infant tolerability

From: Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: a phase I clinical trial

Tolerability Assessment BiLS (n = 34) LS (n = 33)
  Baseline Intervention Post-Intervention Baseline Intervention Post-Intervention
  Mean SD Mean SD Mean SD Mean SD Mean SD Mean SD
Temperature Above 100.3F, % (# days)a 0.005 0.029 0.000 0.000 0.000 0.000 0.005 0.029 0.000 0.000 0.001 0.005
Blood in Stool, % (# days)a 0.000 0.000 0.003 0.016 0.002 0.010 0.000 0.000 0.000 0.000 0.005 0.031
Antibiotic Use, % (# days)a 0.000 0.000 0.000 0.000 0.000 0.000 0.000 0.000 0.013 0.073 0.000 0.000
Medication for Gas, % (# days)a 0.015 0.086 0.038 0.088 0.084 0.194 0.005 0.029 0.059 0.167 0.142 0.254
Jaundice diagnosis, % (n)b 26.5% (9) 5.9% (2) 0% (0) 26.5% (9) 8.8% (3) 2.9% (1)
Colic, Parental Report, % (n)b 0% (0) 0% (0) 5.9% (2) 5.9% (2) 8.8% (3) 8.8% (3)
Eczema diagnosis, % (n)b 0% (0) 0% (0) 5.9% (2) 0% (0) 0% (0) 8.8% (3)
Illnesses, % (# reports)b 2.9% (1) 11.8% (4) 20.6% (7) 2.9% (1) 8.8% (3) 17.6% (6)
Sick Doctor Visits, % (# reports)b 2.9% (1) 15% (5) 15% (5) 0% (0) 2.9% (1) 12% (4)
  1. aProportions were calculated as: (number of days reported)/total number of days in each study period
  2. bPercentages were calculated as: (number of infants for which condition appeared or was diagnosed) /total number of infants in each intervention group during each study period*100