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Table 2 Additional information collected

From: Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial

Measure

Timing (D = days/M = months)

Information

Details

 

0

D7

D14

D21

D28

M6

  

Questionnaire

â– 

     

Demographics

 

Questionnaire

â– 

     

Potential confounders

Family history of atopy. Antenatal / current probiotic / antibiotic use. Smoking during pregnancy. Mode of delivery (caesarean versus vaginal).

Diary questions

â– 

â– 

â– 

â– 

â– 

â– 

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– 

 

Compliance

Number of days study drops missed over preceding week.

Diary questions

â– 

â– 

â– 

â– 

â– 

 

Side effects

Infant stool frequency, consistency.

Physical examination

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– 

 

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– 

 

Quantitative PCR

A molecular method to detect and measure the presence of particular marker genes of L reuteri, as a measure of compliance [77].