An Infant Formula Trial on Dietary Management of Infantile Colic

Study Overview
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Brief Summary
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A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.

Detailed Description
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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)

Official Title
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A Randomised, Double Blind, Controlled, Multi-centre Study to Assess the Efficacy of an Infant Formula in the Dietary Management of Infantile Colic

Conditions
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Infantile Colic

Intervention / Treatment
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* Other: Specific hydrolysed proteins
* Other: Standard cow's milk with prebiotics mixture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants aged 21-56 days (both inclusive); Gestation age 37-42 weeks; Normal birth weight for gestational age and gender 5-minute APGAR score >7; Diagnosed with infantile colic ; Fully formula fed for at least 7 days before randomisation; Written informed consent from the parent and/or legal representative. 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; Congenital condition and/or previous or current illness/infection and (or) medication use that could interfere with the main study outcomes; Known cow's 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 subject to comply with the protocol requirements; Current participation in another clinical study involving investigational or marketed products.

Ages Eligible for Study
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Minimum Age: 21 Days
Maximum Age: 56 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, two arms
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose | Other: Specific hydrolysed proteins<br>* An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose<br>|
| Active Comparator: Control group<br>Standard cow's milk with prebiotics mixture | Other: Standard cow's milk with prebiotics mixture<br>* Standard cow's milk with prebiotics mixture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily inconsolable crying time using data recorded on subject's diaries | Daily inconsolable crying time over 6 weeks | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily crying time using data recorded on subject's diaries | Daily crying time over 6 weeks of intervention | 6 weeks | 
| Daily fussing time using data recorded on subject's diaries | Daily fussing time over 6 weeks of intervention | 6 weeks | 
| Daily inconsolable fussing time using data recorded on subject's diaries | Daily inconsolable fussing time over 6 weeks of intervention | 6 weeks | 
| Daily stool frequency using data recorded on subject's diaries | Daily stool frequency over 6 weeks of intervention | 6 weeks | 
| Daily stool consistency using data recorded on subject's diaries | Daily stool consistency over 6 weeks of intervention | 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 | 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 | 6 weeks |