Safety and Tolerance of a Partly Fermented Infant Formula With Prebiotic Oligosaccharides in Healthy Infants

NCT03476889 | Unknown

• 1 other identifier: EBB17TA14644
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

A randomised, controlled, double-blind, parallel group, multi-country study to investigate the safety and tolerance of a partly fermented infant formula containing prebiotic oligosaccharides in healthy term infants.

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

• Weight gain (infant formula comparison)

  Equivalence of weight gain per day (g/d) from baseline until 17 weeks of age in subjects receiving the test product compared to infants receiving the control product

  17 weeks

Secondary Outcomes (7)

• Weight gain (human milk comparison)

  17 weeks

• Recumbent Length gain

  17 weeks

• Head circumference gain

  17 weeks

• Parent-reported GI Tolerance Parameters (daily diary)

  17 weeks

• Parent-Reported Stool Characteristics (adapted Amsterdam Stool Scale)

  17 weeks

Study Arms (3)

Intervention

EXPERIMENTAL

Cows milk based infant formula containing fermented infant formula and prebiotic oligosaccharides

Other: Infant formula

Control

ACTIVE COMPARATOR

Cows milk based infant formula containing prebiotic oligosaccharides (commercially available Aptamil ProNutra)

Other: Infant formula

Breastfed reference

NO INTERVENTION

Exclusively breastfed from birth to study completion

Interventions

Infant formula OTHER

Infants are randomized to one of two infant formulas from \<14 days of age to 17 weeks of age.

Control; Intervention

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy, singleton, term infants
• Aged ≤14 days at randomisation/enrolment
• Birth weight within normal range for gestational age and sex
• Head circumference at birth within normal range for age and sex
• Maternal age ≥18 years at birth;
• Intervention arms: exclusively formula fed at randomisation (infants of mothers who autonomously chose not to breastfeed for any reason before their infant is ≤14 days of age, and who intend to exclusively formula feed until their infant is at least 17 weeks of age); OR Breastfed reference arm: exclusively breastfed at enrolment (infants of mothers who intend to exclusively breastfeed until their infant is at least 17 weeks of age);
• Written informed consent from parent(s) and/or legal guardian(s), who themselves are aged ≥18 years.

You may not qualify if:

• Infants who require to be fed a special diet other than standard cow's milk based infant formula;
• Infants known or suspected to have cow's milk allergy, soy allergy and/or lactose intolerance;
• Infants known or suspected to have current or previous illnesses/conditions or interventions which could interfere with the study or its outcome parameters, as per the clinical judgement of the Investigator;
• Infants with known or suspected congenital diseases or malformations which could interfere with the study or its outcome parameters (including, but not limited to: GI malformations, congenital immunodeficiency), as per the clinical judgement of the Investigator;
• Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products;
• Incapability of infants' parents/legally acceptable representatives to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parent(s)/legally acceptable representative(s) to comply with the protocol requirements;
• Infants born from mothers with significant medical conditions during pregnancy that might interfere with the study or known to affect intra-uterine growth (e.g. placenta previa, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oral medication) as per Investigator's judgement.
• Criteria for lactating mothers of subjects in the breastfed reference arm:
• Lactating women who are currently participating or intend to participate in any other clinical study involving investigational products. Participation in purely observational studies is permitted;
• Lactating women known to suffer from hepatitis B or human immunodeficiency virus;
• Lactating women known to have any other significant medical condition(s) which might interfere with the study or its outcome parameters (breast abscess or mastitis which could interfere with lactation, or other clinically relevant infections, or consumption of medication/substances which could impact the infants' growth), as per the clinical judgement of the Investigator;
• Lactating women who intend to feed their infants with a combination of human milk and infant formula.

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (1)

Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k.

Bialystok, 15-435, Poland

RECRUITING

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Central Study Contacts

Jan van der Mooren, MD, PhD

CONTACT

+31 30 295000; jan.vandermooren@danone.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 26, 2018
• Study Start: July 19, 2018
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: September 10, 2018

Record last verified: 2018-03

Locations

PL (1)