Synbiotics and Growth

June 25, 2013 updated by: Société des Produits Nestlé (SPN)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

311

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90127
        • Istituto di Ostetricia e Genecologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Standard starter infant formula
starter infant formula from enrollment till 16 weeks of age
Other: Infant formula
infant formula
Experimental: starter infant formula with prebiotics
starter infant formula from enrollment till 16 weeks of age
Other: Infant formula
infant formula
Experimental: starter infant formula with pro and prebiotics
starter infant formula from enrollment till 16 weeks of age
Other: Infant formula
infant formula
Other: breastfeeding group
exclusively breastfeeding during the first 16 weeks of age
Other: Breastfeeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean weight gain (g/day)
Time Frame: over 16 weeks
over 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
length (cm), head circumference (cm)
Time Frame: over 1 year
over 1 year
• digestive tolerance (stool characteristics and frequency, vomiting, spitting up, frequency of colic)
Time Frame: over 4 months
over 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (Estimate)

June 26, 2013

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 05.23.INF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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