Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic

Study Overview
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Brief Summary
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The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic. Primary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula.

Official Title
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Evaluation of the Safety and Efficacy of New Infant Formula and Its Effects on the Gastrointestinal Tolerance (Crying Time) in Infantile Colic: a Double-blind, Randomized, Controlled Intervention Study

Conditions
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Infantile Colic

Intervention / Treatment
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* Other: control formula
* Other: intervention formula 1
* Other: intervention formula 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy term infants Subjects appropriate for gestational age between 35 and 41 weeks Subjects between 15-60 days old Subjects with birth weight between 2500 and 4200 g and regular weight gain (≥150g / week) Diagnosis of infantile colic according to modified Wessel criteria (Crying episodes lasting 3 or more hours/day and occurring at least 3 days/week for at least 1 week) Subjects exclusively bottle-fed at study entrance Day care of the child only by mother/father Provide written informed consent in accordance with legal requirement Exclusion Criteria: Neonatal problems (respiratory distress, asphyxia, Hypoglycaemia, sepsis, NEC) Clinical evidence of chronic illness or gastrointestinal disorders (GER, gastroenteritis) Assumption of any kind of medication (except vitamin D, vitamin K and fluoride prophylaxis) during the week before the beginning of the study and during the study period Subjects receiving formula for special medical purposes Exclusively breast-fed infants Feeding of supplemental Pro- and/or Prebiotics two weeks prior to inclusion Allergic diseases (manifest atopic dermatitis, cow's milk allergy) Participation in any other clinical intervention

Ages Eligible for Study
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Minimum Age: 15 Days
Maximum Age: 60 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control formula<br>infants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol | Other: control formula<br>* commercial stage 1 infant formula<br>|
| Experimental: intervention formula 1 group<br>infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol | Other: intervention formula 1<br>* infant formula with hydrolyzed protein (type I) and pre- and probiotics<br>|
| Experimental: intervention formula 2 group<br>infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol | Other: intervention formula 2<br>* infant formula with hydrolyzed protein (type II) and pre- and probiotics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily total crying time | evaluation of the difference in the average reduction of daily crying time after 28 days of intervention between treatment and control group | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth parameters | determination of body weight, length, head circumference | 90 days | 
| tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects | stool characteristics: frequency, consistency and color; gastrointestinal disorders: regurgitation, obstipation; side effects: vomiting, diarrhea, skin reactions | 28 days | 
| formula intake | evaluation of average daily drinking amount and formula acceptance | 28 days | 
| intestinal microbiota | evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention | 0-28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant nutrition, infantile colic