Human Milk Oligosaccharides (HMOs) - Post Marketing Study on Infants (NeHMO)

Growth and Feeding Tolerance of Infants Consuming a Formula Supplemented With Human Milk Oligosaccharides (HMOs): An Uncontrolled, Open-label, Prospective Study

Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT). Two published RCTs have demonstrated that infant formulas supplemented with 2'FL or 2'FL+LNnT are safe, well-tolerated, support normal grow, and may support healthy GI function and confer immune benefits. The performance of HMOs-supplemented formulas assessed in a real-world setting is complementary to previously conducted RCTs conducted in highly controlled clinical settings. Main objectives will be to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs in a real-world setting. In addition to it considering the potential health/immune benefits of HMOs, it is also important explore the incidences of illnesses (i.e., respiratory illnesses, GI illnesses, and fever) associated with consuming HMOs-supplemented formulas.

Objectives:

The main objective of this study is to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs for 8 weeks (56 days), in a real-world setting.

Main endpoints:

1. Growth documented via monitoring the anthropometric parameters including weight, length, head circumference, BMI and their corresponding z-scores (i.e., z-scores for weight-for-age, length-for-age, weight-for-length, head circumference-for-age, and BMI-for-age) calculated using the 2006 WHO Growth Standards
2. Feeding tolerance assessed via monitoring parent-reported overall GI symptom burden measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score (13-item summary score)

Additional objectives:

To describe the following outcomes in infants fed an infant formula supplemented with HMOs:

1. Formula acceptability
2. Despite there are no expected safety concerns, standard Adverse Events (AEs) monitoring will be implemented during the study

Additional endpoints:

1. Formula acceptability assessed by the Study Formula Satisfaction Questionnaire

2. Reported AEs and Serious Adverse Events (SAEs) including type, incidence, severity, seriousness and relation to study formula consumption as well as concomitant medications and non-pharmacological treatments.

   • Select morbidities of interest (i.e., respiratory illnesses, GI illnesses, and fever) will be collected as part of AE reporting and specific corresponding AE guidance forms will be used to standardize reporting of such AEs

Trial design:

Uncontrolled, single arm, open-label, prospective study in infants (enrolled at postnatal age 7 days to 2 months) fed the study formula for 8 weeks (56 days)

Trial population:

Healthy, male and female, term infants, 7 days postnatal age to 2 months of age at the enrollment

Treatment duration:

Total study participation/intervention up to approximately 8 weeks

Inclusion Criteria:

1. Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) has been informed of all pertinent aspects of the study
2. Parent(s) Are willing and able to fulfill the requirements of the study protocol
3. Healthy full term (37-42 weeks gestation) infant
4. Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
5. Parent(s) must have independently elected, before enrollment, to formula feed. IF or mixed feeding. Prior to enrollment parents were counselled about the superiority and advantages of exclusive breastfeeding.

Exclusion Criteria:

1. Had any known case of intolerance/allergy to cow's milk (for formula-fed group only)
2. Had conditions requiring infant feedings other than those specified in the protocol
3. Evidence of significant cardiac, respiratory, endocrinologist, hematologic, gastrointestinal, or other systemic diseases/disorders
4. Parent(s) refusal to participate in the study
5. Infant had consumed any other infant formula in 3 days prior to study start