Table 2

Additional information collected
Measure Timing (D = days/M = months) Information Details
0 D7 D14 D21 D28 M6
Questionnaire Demographics
Questionnaire Potential confounders Family history of atopy. Antenatal / current probiotic / antibiotic use. Smoking during pregnancy. Mode of delivery (caesarean versus vaginal).
Diary questions Potential confounders Infant feeding method (breast versus formula). Mother’s intake of dairy, probiotics, medications. Infant’s intake of dairy, probiotics, solids, medications. Infant gastro-oesophageal reflux symptoms (measured by the Infant Gastroesophageal Reflux Questionnaire Revised I-GERQ-R [75,76], a validated measure of infant gastro-oesophageal reflux). Settling techniques. Concurrent illnesses / immunisations.
Diary questions Compliance Number of days study drops missed over preceding week.
Diary questions Side effects Infant stool frequency, consistency.
Physical examination To exclude organic causes of crying Infants recruited through Maternal Child Health Nurses and Tweddle are examined by the study paediatrician.
Weight Weight (kg, to nearest gram) Measured by the Wedderburn Infant Scale (Tanita Baby Scale Model BD590) calibrated for the study.
Infant faecal L reuteri (cfu/ml) Quantitative PCR A molecular method to detect and measure the presence of particular marker genes of L reuteri, as a measure of compliance [77].

Sung et al.

Sung et al. BMC Pediatrics 2012 12:135   doi:10.1186/1471-2431-12-135

Open Data