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

Phase 2

Completed

• Conditions: Growth
• Interventions: Other: Standard Infant Formula; Other: Infant Formula with prebiotics

• Registration Number: NCT03062761
• Lead Sponsor: Nutricia Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-22
• Study First Posted: 2017-02-23
• Study Start: 2017-04-27
• Primary Completion: 2018-10-26
• Study Completion: 2018-11-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

1. Healthy term infants (gestational age ≥ 37 weeks + 0 days and ≤ 41 weeks + 6 days);
2. Infants' age at enrolment ≤ 14 days;
3. 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);
4. Head circumference at inclusion within normal range for age and sex (within 2 SD curves according to WHO Child Growth Standards - or local growth standards if available);
5. 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.

Exclusion Criteria

Infants of pregnant women/mothers:

1. who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;

2. 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:

3. 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:

4. who have to be fed with a special diet other than standard (non-hydrolysed) cow's milk based infant formula

5. 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;

6. with any history of, or current participation in any other study involving investigational or marketed products.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control product: standard formula (intact protein)	Standard Infant Formula	Intact cow's milk protein based infant formula containing prebiotics.
Active product: partially hydrolysed proteins	Infant Formula with prebiotics	Partially hydrolysed whey protein based infant formula containing prebiotics.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Vomiting	4, 8, 13 and 17 weeks	Vomiting nr of occurrences per week
Diarrhoea	4, 8, 13 and 17 weeks	Number of infants with diarrhoea (definition adapted from WHO definition based on number of watery stools per day)
Albumin level	17 weeks	Albumin in blood (g/L)
Length	17 weeks	Gain in Recumbent length (mm/day)
Mid-upper arm circumference	17 weeks	Gain in Mid-upper arm circumference (mm/day)
Phosphorus level	17 weeks	Phosphorus in blood (mmol/l)
Magnesium level	17 weeks	Magnesium (mmol/l) in blood
Nitrogen level	17 weeks	Blood urea nitrogen (mmol/l)
Number of subjects with adverse events	17 weeks	Adverse events (by "System/Organ Class" and "Preferred term" according the MedDRA ) will be reported as number of subjects with at least one adverse event
Anthropometric measures	17 weeks	Z scores of anthropometric parameters
Iron level	17 weeks	Iron (µmol/l) in blood
Regurgitation	4, 8, 13 and 17 weeks	Regurgitation nr of occurrences per week
Constipation	4, 8, 13 and 17 weeks	Number of infants with constipation (definition adapted from Rome II criteria based on number of defecations and consistency per week)
Head circumference	17 weeks	Gain in Head circumference (mm/day)
Number of adverse events	17 weeks	Number of adverse events (by "System/Organ Class" and "Preferred term" according the MedDRA)
Calcium level	17 weeks	Calcium in blood (mmol/l)
Concomitant medications	17 weeks	All concomitant medications (according to WHO-DDE) will be summarised in individual data listing

Trial Locations

Locations (15)

Korczowski Bartosz, Gabinet Lekarski; 🇵🇱 Rzeszów, Poland

Vivantes Klinik für Geburtsmedizin, Klinikum Neukölln; 🇩🇪 Berlin, Germany

Paediatric Practice; 🇩🇪 Bramsche, Germany

Hospices Civils de Lyon; 🇫🇷 Lyon, France

University of Turku Children's Allergy and Asthma Clinic; 🇫🇮 Turku, Finland

Groupement des Hopitaux de l'institut Catholique de Lille; 🇫🇷 Lille, France

Gelre Ziekenhuizen; 🇳🇱 Apeldoorn, Netherlands

Poliklinika Ginekologiczno-Poloznicza Sp. z o.o. Sp.k; 🇵🇱 Białystok, Poland

Specjalistyczna Poradnia Medyczna Przylądek Zdrowia; 🇵🇱 Kraków, Poland

NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska; 🇵🇱 Siemianowice Śląskie, Poland

POLMED / Instytut Mikroekologii; 🇵🇱 Poznań, Poland

Hospital Quirónsalud Barcelona; 🇪🇸 Barcelona, Spain

Hospital General Universitario de Elche; 🇪🇸 Elche, Spain

Hospital Universitari Sant Joan de Reus (IISPV); 🇪🇸 Reus, Spain

Hospital Universitari de Tarragona Joan XXIII; 🇪🇸 Tarragona, Spain