Feeding Intervention for Infants With Crying

Study Overview
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Brief Summary
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The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula.

Official Title
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Effects of an Infant Formula With Probiotics on Signs and Symptoms of Colic.

Conditions
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Crying

Intervention / Treatment
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* Other: Milk based infant formula with probiotic
* Other: Milk based infant formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: full term infants greater than or equal to 37 wks gestation 3 weeks to less than or equal to 4 months of age upon enrollment experiencing ongoing crying and fussy episodes of a minimum of 3 hours of crying /day for 3 days in a week for at least one week prior to enrollment otherwise healthy as reported by parent/caregiver is under the care of a pediatrician or other qualified healthcare professional and has had at least one postnatal visit taking no more than one feeding of breast milk per day having not initiated weaning foods or beverages other than infant formula or breast milk study explained and written information provided with Parent/caregiver demonstrating understanding of the given information informed consent signed(parent/legal representative) Exclusion Criteria: Chromosomal or major congenital anomalies known cow's milk allergy receiving any type of therapeutic formula (including extensively hydrolyzed formula or free amino acid formula) receiving an antibiotic or probiotic in the week prior to enrollment complicated reflux, defined by reflux combined with inadequate growth and/or respiratory complications infant's family, who in the investigator's assessment, cannot be expected to comply with the protocol infant currently participating in another conflicting clinical study

Ages Eligible for Study
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Minimum Age: 3 Weeks
Maximum Age: 4 Months

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infant formula with probiotic<br>Infant formula with probiotic for 0 to 12 months of age | Other: Milk based infant formula with probiotic<br>* formula supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days duration<br>|
| Placebo Comparator: Standard infant formula<br>Infant formula for 0 to 12 months of age | Other: Milk based infant formula<br>* supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily total crying time |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formula intake |  | 4 days | 
| Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies |  | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infants, formula, probiotic, crying