Treem 1991.

Methods	Double‐blind, randomised, 2‐period, cross‐over trial with 2 treatment groups
Participants	Sample size: 33 infants (6 dropped out – sequence group not clear) Setting: paediatricians in the greater Hartford community, Connecticut, USA Sex: 13 boys (48%) 14 girls (52%) Mean age: 34 days (SD not reported, range 10 to 54) Mean weight: not reported Mean duration of colic (baseline): not reported Mean crying (baseline): not reported Feeding: formula fed (100%) Birth order: 15 first born Inclusion criteria: crying as if in pain, crying suddenly, crying continuously for more than 15 min at a time, and difficult or impossible to console during these crying spells, with colic defined as more than 3 h crying or fussing per day on at least 3 days out of 6 successive days, birth weight > 2500 g, normal gestational age, absence of neonatal problems, normal weight gain (> 150 g/week), normal physical examination Exclusion criteria: infants on medications during the first week before or during the study
Interventions	Intervention (n = 12): Isomil with soy polysaccharide added to increase dietary fibre (mean values 14.1 g dietary fibre per litre) Control (n = 15): Isomil with nothing added (mean values 3.1 g dietary fibre per litre) Duration: baseline for 1 week before beginning study. Cross‐over study, including 3‐day washout between 2 × 9‐day‐long arms of study. Patients seen 5 times during the study: at the beginning of the baseline period, at each of the 2 × 9‐day study periods, at the end of the last 9‐day period, and at the 30‐ to 35‐day follow‐up period. Parents also contacted by telephone at least once during each of the 2 × 9‐day study periods
Outcomes	Daily behaviour, feeding, and stool diaries completed for 27 days. At the end of this time, parents asked to indicate during which study period the symptoms of colic were most alleviated and whether the infant's symptoms were alleviated during one of the study periods more than during any time before the study. We did not include these data in our analysis as we were looking only at the first arm. Results for crying and fussing in min per 24 h, but aggregated cross‐over data
Notes	Study start and end dates not reported COIs: none reported Funding source: supported by grants from Ross Laboratories Adverse effects: not reported Comments: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: randomised
Allocation concealment (selection bias)	High risk	Comment: no details. Wrote to study author but received no response
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: double‐blind and disguised
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: no details. Wrote to study author but received no response
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: accounted for all participants
Selective reporting (reporting bias)	High risk	Comment: accounted for all participants, adverse effects not reported
Other bias	High risk	Comment: supported by grants from Ross Laboratories who make Isomil. No further details of involvement were available from the study author

COIs: conflicts of interest; GP: general practitioner; HV: health visitor; SD: standard deviation; SPSS: Statistical Package for the Social Sciences.