Human Milk Oligosaccharides (HMOs) Post-market Study on Infants
Condition: Growth; Tolerance; Adverse Event; Disorder of Intestine; Disorder Lung
MeSH terms: Intestinal Diseases
Study type: Interventional

Summary: 
      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 monitor the safety & tolerance of
      HMOs-supplemented formulas in larger and diverse infant populations; to assess the
      performance of HMOs-supplemented formulas in mixed-fed infants, a population that was not
      studied in previous RCTs but likely represents a relatively common feeding regimen. Finally,
      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 and compare with breastfed infants data.
    

Detailed description: 
      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)

      A group of exclusively breastfed infants (BF) will serve as a reference group in parallel to
      the study arm. For the BF group, Infants must have been exclusively consuming breast milk
      since birth, and their parent(s) must have made the decision to continue exclusively
      breastfeeding until at least 4 month of age

      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
    

Intervention name(s): HMO-supplemented infant formula
Intervention type(s): Other
Intervention description(s): Starter Infant Formula supplemented with 1.5g/L of Human Milk Oligosaccharides
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Growth; Tolerance; Adverse Event; Gastrointestinal disorder; Respiratory infection; Gastrointestinal infection