Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics

NCT01036243 | Completed

• 1 other identifier: 07.06 INF
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant Nutrition

Keywords

digestive tolerance; night sleep; crying; growth

Outcome Measures

Primary Outcomes (1)

• incidence of crying/fussing from 1 to 3 months.

  3 months

Secondary Outcomes (1)

• growth and night sleep

  6 months

Study Arms (4)

Test formula 1

EXPERIMENTAL

Hydrolyzed formula with probiotics

Dietary Supplement: test formula 1

test formula 2

ACTIVE COMPARATOR

acidified hydrolyzed formula.

Dietary Supplement: test formula 2

Test formula 3

ACTIVE COMPARATOR

hydrolyzed formula without probiotics

Dietary Supplement: test formula 3

reference product

ACTIVE COMPARATOR

standard infant formula

Dietary Supplement: reference formula

Interventions

test formula 1 DIETARY_SUPPLEMENT

hydrolyzed formula with probiotics

Also known as: for 0-6 months as per standard requirement

Test formula 1

test formula 2 DIETARY_SUPPLEMENT

acidified hydrolyzed formula

Also known as: suitable for 0-6 months as per standard requirement

test formula 2

test formula 3 DIETARY_SUPPLEMENT

hydrolyzed formula without probiotics

Also known as: suitable for 0-6 months of age as per standard requirement

Test formula 3

reference formula DIETARY_SUPPLEMENT

standard infant formula

Also known as: suitable for 0-6 months of age as per standard requirement

reference product

Eligibility Criteria

• Age: 11 Days - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Chulalongkorn University: collaborator

Study Sites (1)

Chulalongkorn University

Bangkok, Thailand

Location

MeSH Terms

Conditions

Crying

Interventions

Aging

Condition Hierarchy (Ancestors)

Nonverbal Communication; Communication; Behavior

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Study Officials

• A/Prof. Boosba Vivatvakin, MD

  Pediatric Gastroenterology Unit,Faculty of Medicine, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

TH (1)