Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics

Infant Nutrition Clinical Trial

Official title:

Tolerance of a Slightly Hydrolyzed Starter Formula Containing Probiotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01036243
• Other study ID #: 07.06 INF
• Status: Completed
• Phase: N/A
• First received: December 17, 2009
• Last updated: June 21, 2012
• Start date: December 2009
• Est. completion date: April 2012

Study information

• Verified date: June 2012
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: April 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infant Nutrition

Intervention

Dietary Supplement:
• test formula 1
hydrolyzed formula with probiotics
• test formula 2
acidified hydrolyzed formula
• test formula 3
hydrolyzed formula without probiotics
• reference formula
standard infant formula

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Nestlé	Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of crying/fussing from 1 to 3 months.		3 months	No
Secondary	growth and night sleep		6 months	No