An interventional study of Specific hydrolysed proteins and Standard cow's milk with prebiotics mixture in Infantile Colic, sponsored by Danone Asia Pacific Holdings Pte, Ltd.. Terminated at 2 sites in 2 countries. Open to participants aged 21 Days to 56 Days. Per ClinicalTrials.gov, last updated 2018-09-10.
Sponsored by Danone Asia Pacific Holdings Pte, Ltd. · Not applicable, Interventional, and Other
A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.
A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.
The hypothesis of the study is that the test product, compared to the control formula, will reduce the crying time in infants with infantile colic.
The various time points of the outcome are:
V1 (screening : Day -5 to day 0); V2 ( Randomization: Day 0); V3 (Day 7); V4 (Day 21); Phone Call (Day 28); V5 (End -intervention: Day 42); V6 (Day 56)
Exclusion Criteria:
Received any of the following products/medication within 7 days before randomisation:
An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose
Other: Specific hydrolysed proteins
Standard cow's milk with prebiotics mixture
Other: Standard cow's milk with prebiotics mixture
An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose
Standard cow's milk with prebiotics mixture
Daily inconsolable crying time using data recorded on subject's diaries
Daily inconsolable crying time over 6 weeks
Time frame: 6 weeks
Daily crying time using data recorded on subject's diaries
Daily crying time over 6 weeks of intervention
Time frame: 6 weeks
Daily fussing time using data recorded on subject's diaries
Daily fussing time over 6 weeks of intervention
Time frame: 6 weeks
Daily inconsolable fussing time using data recorded on subject's diaries
Daily inconsolable fussing time over 6 weeks of intervention
Time frame: 6 weeks
Daily stool frequency using data recorded on subject's diaries
Daily stool frequency over 6 weeks of intervention
Time frame: 6 weeks
Daily stool consistency using data recorded on subject's diaries
Daily stool consistency over 6 weeks of intervention
Time frame: 6 weeks
The frequency of subject's GI symptoms of digestion in the 7-day period prior to the visit using the Infant gastrointestinal symptoms questionnaire
Gastrointestinal symptoms using the Infant gastrointestinal symptoms questionnaire during the 6-week intervention period
Time frame: 6 weeks
The intensity of subject's GI symptoms of digestion in the 7-day period prior to the visit using the Infant gastrointestinal symptoms questionnaire
Gastrointestinal symptoms using the Infant gastrointestinal symptoms questionnaire during the 6-week intervention period
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Danone Asia Pacific Holdings Pte, Ltd.