A Clinical Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants

NCT03062761 | Completed Phase 2

• 1 other identifier: EBB15BL89832
• Study Type: interventional
• Target: 380
• Locations: 6 countries
• Sites: 15

Brief Summary

It is universally accepted that the best nutrition for a new-born infant is breast milk. Breast milk provides a complete set of nutrients to support growth and development of children in early life, including components that have a beneficial effect on gut health and the body's ability to defend itself against infectious organisms and other invaders (immune system).However, it may occur that a mother is unable to breastfeed her child, or chooses not to breastfeed. In such cases, an infant formula inspired by breast milk is the best alternative. Research is done to optimize milk formula for infants. One of these formulas contains 'partially hydrolyzed' proteins instead of intact proteins, meaning the proteins in this formula are broken down into smaller pieces. These smaller pieces of protein make the milk more suitable for consumption by infants at risk of developing cow's milk allergy. These types of partially hydrolyzed protein formulas have been on the market for several years, in particular for children with a family risk of allergy. So far, no safety related issues have been reported. It is also known that weight gain of infants receiving partially hydrolyzed proteins in general is appropriate according to the World Health Organisation growth standards. The main purpose of the TENUTO study is to demonstrate that infants who receive a specific partially hydrolyzed protein infant formula for the first 4 months of life have a similar weight gain compared to infants receiving standard infant formula with intact proteins. A group of infants who receive breast milk only is also included for comparison.

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

• Weight gain

  Weight gain in grams per day from baseline until 17 weeks of age

  17 weeks

Secondary Outcomes (17)

• Length

  17 weeks

• Head circumference

  17 weeks

• Mid-upper arm circumference

  17 weeks

• Anthropometric measures

  17 weeks

• Albumin level

  17 weeks

Study Arms (2)

Active product: partially hydrolysed proteins

EXPERIMENTAL

Partially hydrolysed whey protein based infant formula containing prebiotics.

Other: Infant Formula with prebiotics

Control product: standard formula (intact protein)

ACTIVE COMPARATOR

Intact cow's milk protein based infant formula containing prebiotics.

Other: Standard Infant Formula

Interventions

Infant Formula with prebiotics OTHER

Intervention group: Partially hydrolysed whey protein based infant formula containing prebiotics.

Active product: partially hydrolysed proteins

Standard Infant Formula OTHER

Control group: Intact cow's milk protein based infant formula containing prebiotics

Control product: standard formula (intact protein)

Eligibility Criteria

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

You may qualify if:

• Healthy term infants (gestational age ≥ 37 weeks + 0 days and ≤ 41 weeks + 6 days);
• Infants' age at enrolment ≤ 14 days;
• Birth weight within normal range for gestational age and sex (10th to 90th percentile according to the WHO Child Growth Standards - or local growth standards if available);
• Infant formula arms: infants who are exclusively formula fed by time of randomisation with a maximum infants' age of 14 days (infants of mothers who choose not to breastfeed or mothers who cease breastfeeding for any reason before the infant is 14 days of age); OR Breastfeeding reference arm: infants who are exclusively breastfed and whose mothers are intending to exclusively breastfeed their infant at least until the infant is 17 weeks of age; 6 Written informed consent from parent(s) and/or legal guardian(s) aged ≥ 18 years.

You may not qualify if:

• Infants of pregnant women/mothers:
• who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;
• known to have a significant medical condition (including 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 clinical judgement;
• Infants of parents:
• who are incapable to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements;
• Infants:
• who have to be fed with a special diet other than standard (non-hydrolysed) cow's milk based infant formula
• known to have current or previous illnesses/conditions which could interfere with the study or its outcome parameters, such as gastrointestinal malformations, congenital metabolic disorders, immune deficiency or major surgery, as per investigator's clinical judgement;
• with any history of, or current participation in any other study involving investigational or marketed products.

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (15)

University of Turku Children's Allergy and Asthma Clinic

Turku, Finland

Location

Groupement des Hopitaux de l'institut Catholique de Lille

Lille, France

Location

Hospices Civils de Lyon

Lyon, France

Location

Vivantes Klinik für Geburtsmedizin, Klinikum Neukölln

Berlin, Germany

Location

Paediatric Practice

Bramsche, Germany

Location

Gelre Ziekenhuizen

Apeldoorn, Netherlands

Location

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

Bialystok, Poland

Location

Specjalistyczna Poradnia Medyczna Przylądek Zdrowia

Krakow, Poland

Location

POLMED / Instytut Mikroekologii

Poznan, Poland

Location

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, Poland

Location

NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska

Siemianowice Śląskie, Poland

Location

Hospital Quirónsalud Barcelona

Barcelona, Spain

Location

Hospital General Universitario de Elche

Elche, Spain

Location

Hospital Universitari Sant Joan de Reus (IISPV)

Reus, Spain

Location

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Spain

Location

MeSH Terms

Interventions

Infant Formula; Prebiotics

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Dietary Supplements

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: February 3, 2017
• First Posted: February 23, 2017
• Study Start: April 27, 2017
• Primary Completion: October 26, 2018
• Study Completion: November 12, 2018
• Last Updated: January 14, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); NL (1); DE (2); PL (5); FI (1); ES (4)