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

NCT ID: NCT03476889

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-19
• Study Completion Date: 2021-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Infant formula

Intervention Type: OTHER

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

Control

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

Group Type: ACTIVE_COMPARATOR

Infant formula

Intervention Type: OTHER

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

Breastfed reference

Exclusively breastfed from birth to study completion

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Infant formula

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Healthy, singleton, term infants

2. Aged ≤14 days at randomisation/enrolment

3. Birth weight within normal range for gestational age and sex

4. Head circumference at birth within normal range for age and sex

5. Maternal age ≥18 years at birth;

6. 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);

7. Written informed consent from parent(s) and/or legal guardian(s), who themselves are aged ≥18 years.

Exclusion Criteria

1. Infants who require to be fed a special diet other than standard cow's milk based infant formula;

2. Infants known or suspected to have cow's milk allergy, soy allergy and/or lactose intolerance;

3. 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;

4. 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;

5. Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products;

6. 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;

7. 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:

8. 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;

9. Lactating women known to suffer from hepatitis B or human immunodeficiency virus;

10. 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;

11. Lactating women who intend to feed their infants with a combination of human milk and infant formula.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nutricia Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Bialystok, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Jan van der Mooren, MD, PhD

Role: CONTACT

jan.vandermooren@danone.com

+31 30 295000

Facility Contacts

M Arciszewska

Role: primary

Other Identifiers

EBB17TA14644

Identifier Type: -

Identifier Source: org_study_id