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

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ClinicalTrials.gov Identifier: NCT03062761
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Growth Other: Infant Formula with prebiotics Other: Standard Infant Formula Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Controlled, Double Blind, Parallel Group, Multi-country Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants
Actual Study Start Date : April 27, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active product: partially hydrolysed proteins
Partially hydrolysed whey protein based infant formula containing prebiotics.
Other: Infant Formula with prebiotics
Intervention group: Partially hydrolysed whey protein based infant formula containing prebiotics.

Active Comparator: Control product: standard formula (intact protein)
Intact cow's milk protein based infant formula containing prebiotics.
Other: Standard Infant Formula
Control group: Intact cow's milk protein based infant formula containing prebiotics




Primary Outcome Measures :
  1. Weight gain [ Time Frame: 17 weeks ]
    Weight gain in grams per day from baseline until 17 weeks of age


Secondary Outcome Measures :
  1. Length [ Time Frame: 17 weeks ]
    Gain in Recumbent length (mm/day)

  2. Head circumference [ Time Frame: 17 weeks ]
    Gain in Head circumference (mm/day)

  3. Mid-upper arm circumference [ Time Frame: 17 weeks ]
    Gain in Mid-upper arm circumference (mm/day)

  4. Anthropometric measures [ Time Frame: 17 weeks ]
    Z scores of anthropometric parameters

  5. Albumin level [ Time Frame: 17 weeks ]
    Albumin in blood (g/L)

  6. Calcium level [ Time Frame: 17 weeks ]
    Calcium in blood (mmol/l)

  7. Phosphorus level [ Time Frame: 17 weeks ]
    Phosphorus in blood (mmol/l)

  8. Iron level [ Time Frame: 17 weeks ]
    Iron (µmol/l) in blood

  9. Magnesium level [ Time Frame: 17 weeks ]
    Magnesium (mmol/l) in blood

  10. Nitrogen level [ Time Frame: 17 weeks ]
    Blood urea nitrogen (mmol/l)

  11. Number of subjects with adverse events [ Time Frame: 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

  12. Number of adverse events [ Time Frame: 17 weeks ]
    Number of adverse events (by "System/Organ Class" and "Preferred term" according the MedDRA)

  13. Concomitant medications [ Time Frame: 17 weeks ]
    All concomitant medications (according to WHO-DDE) will be summarised in individual data listing

  14. Regurgitation [ Time Frame: 4, 8, 13 and 17 weeks ]
    Regurgitation nr of occurrences per week

  15. Vomiting [ Time Frame: 4, 8, 13 and 17 weeks ]
    Vomiting nr of occurrences per week

  16. Diarrhoea [ Time Frame: 4, 8, 13 and 17 weeks ]
    Number of infants with diarrhoea (definition adapted from WHO definition based on number of watery stools per day)

  17. Constipation [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062761


Contacts
Contact: Jan van der Mooren +31 30 209 5000 jan.vandermooren@danone.com

Locations
Finland
University of Turku Children's Allergy and Asthma Clinic Active, not recruiting
Turku, Finland
Germany
Vivantes Klinik für Geburtsmedizin, Klinikum Neukölln Recruiting
Berlin, Germany
Contact: Dietmar Schlembach       dietmar.schlembach@vivantes.de   
Paediatric Practice Recruiting
Bramsche, Germany
Contact: Thomas Adelt       thomasadelt@yahoo.de   
Netherlands
Gelre Ziekenhuizen Active, not recruiting
Apeldoorn, Netherlands
Poland
Poliklinika Ginekologiczno-Poloznicza Sp. z o.o. Sp.k Recruiting
Białystok, Poland
Contact: Marta Arciszewska-Kasprzak       marta@arciszewska.eu   
Specjalistyczna Poradnia Medyczna Przylądek Zdrowia Recruiting
Kraków, Poland
Contact: Izabela Tarczoń       lekarz@przyladekzdrowia.pl   
POLMED / Instytut Mikroekologii Recruiting
Poznań, Poland
Contact: Tomasz Pikula       tpikula@ump.edu.pl   
Korczowski Bartosz, Gabinet Lekarski Recruiting
Rzeszów, Poland
Contact: Bartosz Korczowski       korczowski@op.pl   
NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska Recruiting
Siemianowice Śląskie, Poland
Contact: Barbara Pajek       michalkowice@of.pl   
Sponsors and Collaborators
Nutricia Research

Responsible Party: Nutricia Research
ClinicalTrials.gov Identifier: NCT03062761     History of Changes
Other Study ID Numbers: EBB15BL89832
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No