Effects of a Synbiotics-containing Starter Formula on Infant Growth

Infant Nutrition Clinical Trial

Official title:

Growth of Infants Consuming Starter Formula Containing Synbiotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010113
• Other study ID #: 09.02 INF
• Status: Completed
• Phase: N/A
• First received: November 5, 2009
• Last updated: April 20, 2012
• Start date: November 2009
• Est. completion date: June 2011

Study information

• Verified date: April 2012
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

Description:

Growth studies continue to be a centrepiece of clinical evaluation of infant formulas. In order to standardize growth, the investigator proposes to calculate the weight-for-age Z-score related to the WHO Child Growth Standards. Z-scores express the difference between the measurement of an individual and the median value of the reference population as a proportion of the SD of the reference population taking into account age and gender.

The hypothesis to be tested is that infants fed with starter formula with prebiotics and probiotics blend and those fed only with probiotics will grow as much as infants in the reference growth of WHO.

Other parameters such as digestive tolerance, frequency of morbidity and microbiota pattern will also be investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 17 Days

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Infant Nutrition

Intervention

Other:
• Standard infant formula with prebiotics
From 0-6 months of age. As per standard requirement
• Infant formula with synbiotics
From 0-6 months of age as per standard requirement

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Nestlé	National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean weight gain		6 months	Yes
Secondary	digestive tolerance		6 months	No