Table 4

Serious Adverse Events

Event CategoryRandomized Control Group (n = 632)Randomized Intervention Group (n = 640)Obtaining Any Probiotic Package (n = 122)Obtaining 2–3 Probiotic Packages (n = 87)
No.% (95% CI)No.% (95% CI)No.% (95% CI)No.% (95% CI)
Respiratory101.6 (0.8–2.9)60.9 (0.3–2.0)10.8 (0.02–4.5)11.1 (0.03–6.2)
Gastrointestinal60.9 (0.3–2.1)101.6 (0.8–2.9)00.0 (0.0–3.0)00 (0–4.2)
Infection (excluding above)20.3 (0.04–1.1)40.6 (0.2–1.6)21.6 (0.2–5.8)11.1 (0.03–6.2)
Other203.2 (1.9–4.8)314.8 (3.3–6.8)10a8.2 (4.0–14.6)66.9 (2.6–14.4)
  • Note: Each category of event is compared according to the randomized groups and the per protocol groups of those receiving additional advice who obtained probiotics, counting number of participants affected by each category of event.

  • a P <.05 compared with control group, adjusted for age and sex.