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. (part of Danone) · 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)
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's enrollment of 5 is below the median of 76 across 110 interventional studies indexed under Colic.
Browse Colic studies →Danone Asia Pacific Holdings Pte, Ltd. is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Received any of the following products/medication within 7 days before randomisation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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