Effects of a Synbiotics-containing Starter Formula on Infant Growth

NCT01010113 | Completed

• 1 other identifier: 09.02 INF
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators want to evaluate the satiety of two infant formulas, one containing prebiotics and the other containing synbiotics. Rate of weight gain, a proxy measurement for the healthy development of an infant, will be assessed in both groups and compared to the growth observed in the WHO Child Growth Standards in order to demonstrate non inferiority.

Conditions

Infant Nutrition

Keywords

infants; prebiotics; probiotics; safety

Outcome Measures

Primary Outcomes (1)

• mean weight gain

  6 months

Secondary Outcomes (1)

• digestive tolerance

  6 months

Study Arms (2)

Test formula 1

PLACEBO COMPARATOR

Standard formula with prebiotics

Other: Standard infant formula with prebiotics

test product

EXPERIMENTAL

Infant formula with synbiotics

Other: Infant formula with synbiotics

Interventions

Standard infant formula with prebiotics OTHER

From 0-6 months of age. As per standard requirement

Test formula 1

Infant formula with synbiotics OTHER

From 0-6 months of age as per standard requirement

test product

Eligibility Criteria

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

You may qualify if:

• Healthy newborn infant
• Age at point of enrolment ≤14 days
• Birthweight ≥2500g and ≤4500g
• Full term infant ≥37 weeks gestation and ≤42 weeks gestation
• Singleton births
• Having obtained his/her or his/her legal representative's informed consent

You may not qualify if:

• Congenital illness or malformation that may affect normal growth
• Significant pre-natal or post-natal disease
• Re-hospitalisation for more than 2 days during the first 14 days of life (Exceptionally, infants hospitalized because of jaundice may be enrolled in the study.)
• Receiving infant formula containing probiotics and/or prebiotics prior to enrollment and/or at the time of enrollment
• Patient who cannot be expected to comply with treatment
• Currently participating or having participated in another clinical trial prior to the beginning of this study

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• National University Hospital, Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Related Publications (1)

• Lee le Y, Bharani R, Biswas A, Lee J, Tran LA, Pecquet S, Steenhout P. Normal growth of infants receiving an infant formula containing Lactobacillus reuteri, galacto-oligosaccharides, and fructo-oligosaccharide: a randomized controlled trial. Matern Health Neonatol Perinatol. 2015 Apr 7;1:9. doi: 10.1186/s40748-015-0008-3. eCollection 2015.

  PMID: 27057326 DERIVED

MeSH Terms

Interventions

Prebiotics; Infant Formula; Synbiotics

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages; Milk Substitutes; Beverages; Food, Formulated; Foods, Specialized; Infant Food; Probiotics

Study Officials

• Dr. Lee Le Ye, MD

  National University Hospital, Singapore

  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: November 5, 2009
• First Posted: November 9, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 23, 2012

Record last verified: 2012-04

Locations

SG (1)