Second Generation Human Milk Oligosaccharides Blend Study

  • STATUS
    Recruiting
  • days left to enroll
    59
  • participants needed
    570
  • sponsor
    Nestlé
Updated on 24 January 2021

Summary

The aim of this trial is to show that infants fed these new formulas, containing a blend of 5 Human Milk Oligosaccharides (HMOs), allow for growth in line with infants fed formulas without HMOs.

There will be different groups in the trial: three formula-fed groups and a breastfed group.

Description

These 5 HMOs are identical to the ones found naturally in human milk. They are natural prebiotics (or complex sugars) with potential health benefits. Prebiotics are natural compounds that help the establishment of beneficial gut bacteria (such as bifidobacteria), while preventing bad bacteria from doing harm. Supplementing diets with certain prebiotics has been shown to be well tolerated in adults and infants and to provide potential benefits.Therefore, the trial also aims to understand if consuming HMOs supplemented formulas could strengthen immunity and prevent common illnesses (for example, respiratory illnesses) in infants and toddlers. Furthermore, stool frequency and consistency will be monitored, so as to evaluate digestive tolerance to the formula.

Details
Condition Healthy Infants
Treatment Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides, Breast-feeding, Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk
Clinical Study IdentifierNCT03722550
SponsorNestlé
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/Legally Acceptable Representative has been informed of all pertinent aspects of the study
Infants whose parent(s)/Legally Acceptable Representative have reached the legal age of majority in the countries where the study is conducted
Infants whose parent(s)/Legally Acceptable Representative are willing and able to comply with scheduled visits, and the requirements of the study protocol
Infants whose parent(s)/Legally Acceptable Representative are able to be contacted directly by telephone throughout the study
Infants whose parent(s)/Legally Acceptable Representative have a working freezer
Infants must meet all of the following inclusion criteria to be eligible for enrollment into the study
Healthy term (37-42 weeks of gestation) infant at birth
At enrollment visit, post-natal age 7 days and 21 days (date of birth = day 0, 0.25 - 0.75 months old)
At enrollment, birth weight 2500g and 4500g
For formula-fed group, infants must be exclusively consuming and tolerating a cow's milk infant formula at time of enrollment and their parent(s)/Legally Acceptable Representative must have independently elected, before enrollment, not to breastfeed
For breastfed group, infants must have been exclusively consuming breast milk since birth, and their parent(s)/Legally Acceptable Representative must have made the decision to continue exclusively breastfeeding until at least 4 month of age

Exclusion Criteria

Infants with conditions requiring infant feedings other than those specified in the protocol
Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrollment
Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including
Evidence of major congenital malformations (e.g., cleft palate, extremity malformation)
Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)
History of admission to the Neonatal Intensive Care Unit (NICU), with the exception of admission for jaundice phototherapy
Other severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the study
Infants who are presently receiving or have received prior to enrollment any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion; or any study outcomes
Currently participating or having participated in another clinical trial since birth
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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