A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocol

Table 3 Outcome measures

Primary outcomes	1. the occurrence of AAD
	2. the occurrence of CDAD
	1. severity¹ and duration of AAD
	2. severity^1,2 and duration of CDAD and incidence of recurrence within the 8-12 weeks follow-up period
	3. abdominal symptoms (abdominal pain, bloating, flatus, nausea)
Secondary outcomes	4. well-being and quality of life assessed using the generic measures EQ-5D and the York SF12 (Iglesias 2001) at recruitment and 4 and 8 weeks
	5. duration of hospital stay
	6. serious adverse effects
	7. acceptability of the probiotic preparation
	8. viability of the probiotic at point of administration
	9. cost-effectiveness

¹Frequency and consistency of stools. ²Additional information extracted from the clinical records (e.g. laboratory parameters, findings at sigmoidoscopy, pseudomembraneous colitis, colectomy, death).

ISSN: 1471-2334