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Table 5 Incidence of infectious disease, febrile episodes and dermatitis during the intervention period

From: Evaluation of the safety, tolerance and efficacy of 1-year consumption of infant formula supplemented with Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263: a randomized controlled trial

  Number of events (N) Incidence Rate
(Standard Error)
Lf vs Control group Bb vs Control group
  Control
(61)
Lf group
(65)
Bb group
(63)
Control Lf group Bb group IRR
(95% CI)
p-value IRR
(95% CI)
p-value
Diarrhoeaa 42 25 49 0.689
(0.106)
0.385
(0.077)
0.778
(0.113)
0.559
(0.326–0.938)
0.014 1.129
(0.745–1.777)
0.750
Upper tract 146 168 132 2.393
(0.212)
2.585
(0.206)
2.096
(0.188)
1.080
(0.829–1.309)
0.673 0.876
(0.663–1.076)
0.223
Lower tract 34 49 44 0.557
(0.101)
0.754
(0.108)
0.700
(0.107)
1.354
(0.814–2.054)
0.190 1.257
(0.756–1.953)
0.293
Conjunctivitis 11 4 8 0.180
(0.054)
0.062
(0.031)
0.127
(0.045)
0.344
(0.080–1.170)
0.071 0.705
(0.246–1.922)
0.473
Otitis 11 11 18 0.180
(0.054)
0.169
(0.051)
0.286
(0.067)
0.939
(0.369–2.387)
0.883 1.589
(0.709–3.712)
0.218
Urine Infection 2 2 1 0.033
(0.023)
0.031
(0.022)
0.016
(0.016)
0.940
(0.069–13.149)
0.958 0.485
(0.008–9.300)
0.540
Fever 32 28 27 0.525
(0.096)
0.431
(0.081)
0.429
(0.084)
0.821
(0.461–1.362)
0.193 0.817
(0.463–1.383)
0.172
Dermatitis 7 2 7 0.115
(0.043)
0.031
(0.022)
0.111
(0.042)
0.270
(0.028–1.430)
0.105 0.965
(0.290–3.235)
0.947
  1. aOf the 42 diarrhea events in the control group, 19 occurred before 6 months and 23 in the period of 6 to 12 months. In the case of the Lf group, of the 25 diarrhea events 8 took place before 6 months and 17 in the period of 6 to 12 months