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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