Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics

Study Overview
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Brief Summary
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To demonstrate that infants have improved gut comfort when fed a slightly hydrolyzed starter formula containing probiotics compared to infants fed a control hydrolyzed and referenced non-hydrolyzed formula.

Detailed Description
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Infants often experience undesirable gastrointestinal effects, such as constipation, flatulence. These symptoms are often perceived by the parents as being related to the diet (formula) the baby is consuming. In another hand, infantile colic or fussing/crying is one of the most commonly encountered problems within the first three months of life. The etiology of the disorder remains unknown however, three main theories have been proposed to explain its origin: (i) psychological: due to inadequate mother-infant interaction (ii) gastrointestinal: such as hypertonicity and immaturity of the GI tract and Dietary factors that may influence the stool pattern in formula fed infants are (iii) allergic: due to a reaction against cow's milk protein or other food constituents. e.g. the protein source, the iron content, hydrolyzation of the protein, or the fat source. It has been reported that infants receiving a casein predominant formula had less unformed stools than those receiving a whey predominant formula. Hydrolysation of protein resulted in reduced gastro-intestinal transit time and some studies using extensively hydrolyzed protein formula have shown more liquid stools. A reduction of crying hours was also described in infant receiving an hydrolyzed formula. Some probiotics were reported with potential benefit on the gut comfort.

Official Title
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Tolerance of a Slightly Hydrolyzed Starter Formula Containing Probiotics

Conditions
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Infant Nutrition

Intervention / Treatment
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* Dietary Supplement: test formula 1
* Dietary Supplement: test formula 2
* Dietary Supplement: test formula 3
* Dietary Supplement: reference formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants, 0-1 month old at point of enrollment Birth weight < 2500g and > 4500g Gestational age < 37 weeks and > 42 weeks Infants who cannot be breastfed because of the maternal status Willing to exclusively consume the assigned study formula with whey protein Are likely to be compliant Mother/caregiver demonstrates an understanding of the given information and ability to record the requested data Exclusion Criteria: Congenital illness or malformation Significant pre-natal and/or post-natal disease Receiving systemic antibiotic treatment at time of enrolment Infant with symptoms of allergy to cow's milk Infant's family cannot be expected to comply with treatment (feeding regimen) Subjects who cannot be expected to comply with treatment Currently participating or having participated in another clinical trial during the last month

Ages Eligible for Study
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Minimum Age: 11 Days
Maximum Age: 30 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 |
| --- | --- |
| Experimental: Test formula 1<br>Hydrolyzed formula with probiotics | Dietary Supplement: test formula 1<br>* hydrolyzed formula with probiotics<br>* Other names: for 0-6 months as per standard requirement;|
| Active Comparator: test formula 2<br>acidified hydrolyzed formula. | Dietary Supplement: test formula 2<br>* acidified hydrolyzed formula<br>* Other names: suitable for 0-6 months as per standard requirement;|
| Active Comparator: Test formula 3<br>hydrolyzed formula without probiotics | Dietary Supplement: test formula 3<br>* hydrolyzed formula without probiotics<br>* Other names: suitable for 0-6 months of age as per standard requirement;|
| Active Comparator: reference product<br>standard infant formula | Dietary Supplement: reference formula<br>* standard infant formula<br>* Other names: suitable for 0-6 months of age as per standard requirement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of crying/fussing from 1 to 3 months. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth and night sleep |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digestive tolerance, night sleep, crying, growth