Synbiotics and Growth

Growth of Infants Fed Starter Formula Containing Oligo-saccharides and the Probiotics Bifidobacterium & Lactobacillus

Sponsors

Lead Sponsor: Nestlé

Source Nestlé
Brief Summary

The primary objective of the trial is to assess the growth of the infants enrolled into the study. Other parameters to be measured include microbiota balance and certain blood biochemical values. In addition the infants' digestive tolerance of the formulae and frequency of morbidity will be investigated.

Detailed Description

The infants will be recruited between birth and 14 days of life and will start on the allocated study formula as soon as they are enrolled. In practice this will tend to be immediately after birth. The treatment period, in terms of data necessary for the primary outcome, will be until they reach 16 weeks old. Growth and other measurements will be collected on five separate occasions during this period, ie 2, 4, 8, 12 and 16 weeks of life. Although the study intervention formally ends at 16 weeks, it will be useful to have a follow up visit at 26 weeks to collect further data on the gut microflora in the sub-group of infants who have already provided a stool sample at 8 weeks. This follow-up visit will be of benefit to the subject as they receive a weight check and clinical examination by a paediatrician and will be offered to all subjects (no invasive procedures will be carried out).

Overall Status Completed
Start Date June 2007
Completion Date October 2009
Primary Completion Date February 2009
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
mean weight gain (g/day) over 16 weeks
Secondary Outcome
Measure Time Frame
length (cm), head circumference (cm) over 1 year
• digestive tolerance (stool characteristics and frequency, vomiting, spitting up, frequency of colic) over 4 months
Enrollment 311
Condition
Intervention

Intervention Type: Other

Intervention Name: Infant formula

Description: infant formula

Intervention Type: Other

Intervention Name: Breastfeeding

Arm Group Label: breastfeeding group

Eligibility

Criteria:

Inclusion Criteria:

- Healthy new-born infant

- Infant is less14 days old on day of enrollment

- Birthweight between 2500g and 4500g

- Gestational age over 37 weeks

- Singleton birth

- Infant's mother, before the 14th day of the child's life, has elected not to breastfeed

- Infant randomized in to a treatment group can expected to be exclusively fed the formula from enrolment until 16 weeks old

- Having obtained his/her legal representative's informed consent

Exclusion Criteria:

- Currently participating in another clinical trial

- Congenital illness or malformation that may affect normal growth

- Significant pre-natal and/or post-natal disease

- Re-hospitalisation for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).

- Receiving antibiotic treatment at time of enrolment or in the 5 previous days.

- Receiving infant formula containing probiotics and/or prebiotics at the time of enrolment

Gender: All

Minimum Age: N/A

Maximum Age: 14 Days

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Istituto di Ostetricia e Genecologia
Location Countries

Italy

Verification Date

June 2013

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 4
Arm Group

Label: Standard starter infant formula

Type: Placebo Comparator

Description: starter infant formula from enrollment till 16 weeks of age

Label: starter infant formula with prebiotics

Type: Experimental

Description: starter infant formula from enrollment till 16 weeks of age

Label: starter infant formula with pro and prebiotics

Type: Experimental

Description: starter infant formula from enrollment till 16 weeks of age

Label: breastfeeding group

Type: Other

Description: exclusively breastfeeding during the first 16 weeks of age

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov