Synbiotics and Growth

NCT01886898 | Completed Phase 3

• 1 other identifier: 05.23.INF
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

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.

Conditions

Infants Growth

Outcome Measures

Primary Outcomes (1)

• mean weight gain (g/day)

  over 16 weeks

Secondary Outcomes (2)

• length (cm), head circumference (cm)

  over 1 year

• • digestive tolerance (stool characteristics and frequency, vomiting, spitting up, frequency of colic)

  over 4 months

Study Arms (4)

Standard starter infant formula

PLACEBO COMPARATOR

starter infant formula from enrollment till 16 weeks of age

Other: Infant formula

starter infant formula with prebiotics

EXPERIMENTAL

starter infant formula from enrollment till 16 weeks of age

Other: Infant formula

starter infant formula with pro and prebiotics

EXPERIMENTAL

starter infant formula from enrollment till 16 weeks of age

Other: Infant formula

breastfeeding group

OTHER

exclusively breastfeeding during the first 16 weeks of age

Other: Breastfeeding

Interventions

Infant formula OTHER

infant formula

Standard starter infant formula; starter infant formula with prebiotics; starter infant formula with pro and prebiotics

Breastfeeding OTHER

breastfeeding group

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Istituto di Ostetricia e Genecologia

Palermo, 90127, Italy

Location

Related Publications (1)

• Meli F, Puccio G, Cajozzo C, Ricottone GL, Pecquet S, Sprenger N, Steenhout P. Growth and safety evaluation of infant formulae containing oligosaccharides derived from bovine milk: a randomized, double-blind, noninferiority trial. BMC Pediatr. 2014 Dec 20;14:306. doi: 10.1186/s12887-014-0306-3.

  PMID: 25527244 DERIVED

MeSH Terms

Interventions

Infant Formula; Lactation

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 26, 2013
• Study Start: June 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 26, 2013

Record last verified: 2013-06

Locations

IT (1)