NCT03329222.

Trial name or title	Title: An infant formula trial on dietary management of infantile colic Official title: A randomised, double‐blind, controlled, multi‐centre study to assess the efficacy of an infant formula in the dietary management of infantile colic
Methods	Double‐blind, randomised controlled trial
Participants	Inclusion criteria Infants aged 21‐56 days (both inclusive) Gestation age 37‐42 weeks Normal birth weight for gestational age and gender 5‐min Apgar (appearance, pulse, grimace, activity, respiration) score >7 Diagnosed with infantile colic Fully formula fed for at least 7 days before randomisation Written informed consent from the parent or legal representative (or both) Exclusion criteria Any plausible cause of inconsolable crying as judged by the investigator Presence of non‐functional vomiting or failure to thrive Presence of any congenital defects in the gastrointestinal system or other defects preventing oral nutrition Combination of congenital condition or previous or current illness/infection and (or) medication use that could interfere with the main study outcomes Known cows' milk protein allergy, lactose intolerance or galactosaemia, including presence of any allergic manifestations Received any special formula (e.g. lactose free, hydrolysed protein) Received any of the following products/medication within 7 days before randomisation: probiotics, systemic antibiotics, prokinetics, proton pump inhibitors Twins or triplets or other infant(s) < 6 months of age living in the same household Incapability of the parent(s) to comply with the study protocol or investigator's uncertainty about the willingness or ability of the participant to comply with protocol requirements Current participation in another clinical study involving investigational or marketed products
Interventions	An infant formula that contains specific hydrolysed proteins with a fat‐blend, prebiotic mixture, starch and reduced lactose versus standard cows' milk with prebiotic mixture
Outcomes	Primary outcome Daily inconsolable crying time using data recorded on participant's diaries (time frame: 6 weeks); daily inconsolable crying time over 6 weeks Secondary outcome Daily crying time using data recorded on participant's diaries (time frame: 6 weeks); daily crying time over 6 weeks of intervention Daily fussing time using data recorded on participant's diaries (time frame: 6 weeks); daily fussing time over 6 weeks of intervention Daily inconsolable fussing time using data recorded on participant's diaries (time frame: 6 weeks); daily inconsolable fussing time over 6 weeks of intervention Daily stool frequency using data recorded on participant's diaries (time frame: 6 weeks); daily stool frequency over 6 weeks of intervention Daily stool consistency using data recorded on participant's diaries (time frame = 6 weeks); daily stool consistency over 6 weeks of intervention The frequency of participants' gastrointestinal symptoms of digestion in the 7‐day period prior to the visit using the Infant Gastrointestinal Symptoms questionnaire (time frame: 6 weeks); gastrointestinal symptoms using the Infant Gastrointestinal Symptoms Questionnaire during the 6‐week intervention period The intensity of participants' gastrointestinal symptoms of digestion in the 7‐day period prior to the visit using the Infant Gastrointestinal Symptoms Questionnaire (time frame: 6 weeks); gastrointestinal symptoms using the Infant Gastrointestinal Symptoms Questionnaire during the 6‐week intervention period
Starting date	27 October 2017
Contact information	Name: Wan Wen Tee; Anneke Ravensbergen Email: wanwen.tee@danone.com; anneke.ravensbergen@danone.com Telephone: +65 68309466; +65 6830 9419
Notes	Status: recruiting Funding source: Danone Asia Pacific Holdings Pte, Ltd