Measure | Timing (D = days/M = months) | Information | Details | |||||
---|---|---|---|---|---|---|---|---|
 | 0 | D7 | D14 | D21 | D28 | M6 |  |  |
Questionnaire | â– | Â | Â | Â | Â | Â | Demographics | Â |
Questionnaire | â– | Â | Â | Â | Â | Â | 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 | â– | â– | â– | â– | â– | Â | Compliance | Number of days study drops missed over preceding week. |
Diary questions | â– | â– | â– | â– | â– | Â | Side effects | Infant stool frequency, consistency. |
Physical examination | â– | Â | Â | Â | Â | Â | To exclude organic causes of crying | Infants recruited through Maternal Child Health Nurses and Tweddle are examined by the study paediatrician. |
Weight | â– | Â | Â | Â | â– | Â | 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) | â– | Â | Â | Â | â– | Â | Quantitative PCR | A molecular method to detect and measure the presence of particular marker genes of L reuteri, as a measure of compliance [77]. |