Clinical trial NCT05150288: Human Milk Oligosaccharides (HMOs) Post-market Study on Infants (NEHMO)
Official title: Growth and Feeding Tolerance of Infants Consuming a Formula Supplemented With Human Milk Oligosaccharides (HMOs): An Uncontrolled, Open-label, Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Tolerance
Adverse Event
Disorder of Intestine
Formula Satisfaction
Keywords: Growth
Tolerance
Adverse Event
Gastrointestinal tolerance
Infant formula
Human milk oligosaccharides
2'-fucosyllactose
Lacto-N-neotetraose
Real-world
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Waldkrankenhaus Protestant Hospital, Spandau
name: Kinderarztpraxis Köllges, Mossakowski und Meyer-Krott, Mönchengladbach
name: Gemeinschaftspraxis Kinder- und Jugendpraxis Dr. Stepan Dreher und Tina Hübler, Geldern
name: Kinder- und Jugendarzt Dr. Umpfenbach und Dr. Lorenz, Viersen
name: Kinder- und Jugendärztliche Gemeinschaftspraxis Bedikian & Bouikidis, Oberhausen
name: Kinderarztpraxis Dr. Zakarian, Düsseldorf
name: Facharztpraxis für Kinder- und Jugendmedizin Dr. Aulinger, Burglengenfeld
name: Zentrum für Kinder- und Jugendgesundheit Regensburg
name: Kinder- und Jugendarztpraxis Schwabach
name: Praxis Dr. Klee, Bürstadt
name: Facharzt für Säuglings-, Kinder- und Jugendmedizin, Bremen
name: Praxis Al-Radhi, Ehingen
name: Kinder und Jugendarztpraxis Dr. Maier, Leinfelden-Echterdingen
name: Kinder- und Jugendarztpraxis Dr. Kröckel, Dr. Ciesla, Berlin
name: Facharzt für Kinder- und Jugendheilkunde Dr. Faustmann, Oberwart
name: Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland
name: Global Medical Affairs, Société des Produits Nestlé S.A., Vevey, Switzerland
First posted: 2021-12-09
Enrollment: 106
Sex: ALL
Minimum age (years): 7
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

Eligibility criteria: Inclusion Criteria:

* Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) have been informed of all pertinent aspects of the study
* Parent(s) are willing and able to fulfill the requirements of the study protocol
* Healthy full term (37-42 weeks gestation) infant
* Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
* Parent(s) must have independently elected, before enrollment, to formula feed

Exclusion Criteria:

* Any known intolerance/allergy to cow's milk (formula-fed group only)
* systemic disorders (cardiac, respiratory, endocrinological, hematologic, gastointestinal, or other)
* conditions requireing infant feedings other than those specified in the protocol
* 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

Primary outcomes:
measure: World Health Organization (WHO) based weight-for-age z-scores
timeFrame: 8 weeks (study end)
measure: World Health Organization (WHO) based length-for-age z-scores
timeFrame: 8 weeks (study end)
measure: World Health Organization (WHO) head-circumference-for-age z-scores
timeFrame: 8 weeks (study end)
measure: World Health Organization (WHO) based body-mass-index (BMI)-for-age z-scores
timeFrame: 8 weeks (study end)
measure: Feeding tolerance
timeFrame: 4 weeks (study midpoint)
measure: Feeding tolerance
timeFrame: 8 weeks (study end)
Secondary outcomes:
measure: Formula acceptability
timeFrame: 4 weeks (study midpoint), 8 weeks (study end)
measure: Standard adverse events (AEs) reporting for safety assessment
timeFrame: From the time the informed consent form has been signed at enrollment infant age less than 7 days to 2 months through the 8 weeks of intervention
measure: Weight
timeFrame: 8 weeks (study end)
measure: Length
timeFrame: 8 weeks (study end)
measure: Head circumference
timeFrame: 8 weeks (study end)
measure: Body-mass-index (BMI)
timeFrame: 8 weeks (study end)
Other outcomes:
Locations:
city: Oberwart
country: Austria
facility: Facharzt für Kinder- und Jugendheilkunde
city: Berlin-Spandau
country: Germany
facility: Evangelisches Waldkrankenhaus Spandau
city: Berlin
country: Germany
facility: Kinder- und Jugensarztpraxis
city: Bremen
country: Germany
facility: Facharzt für Säuglings-, Kinder- und Jugendmedizin
city: Burglengenfeld
country: Germany
facility: Facharztpraxis für Kinder- und Jugendmedizin
city: Bürstadt
country: Germany
facility: Praxis Dr. Klee
city: Düsseldorf
country: Germany
facility: Kinderarztpraxis
city: Ehingen
country: Germany
facility: Praxis Al-Radhi
city: Geldern
country: Germany
facility: Gemeinschaftspraxis Kinder- und Jugendarztpraxis
city: Leinfelden-Echterdingen
country: Germany
facility: Kinder und Jugendarztpraxis
city: Mönchengladbach
country: Germany
facility: Kinderarztpraxis Köllges
city: Oberhausen
country: Germany
facility: Kinder- und Jugendärztliche Gemeinschaftspraxis
city: Regensburg
country: Germany
facility: Zentrum für Kinder- und Jugendgesundheit
city: Schwabach
country: Germany
facility: Kinder- und Jugendarztpraxis
city: Viersen
country: Germany
facility: Kinder- und Jugendarzt
city: Lausanne
country: Switzerland
facility: Nestlé Research, Société des Produits Nestlé S.A.
city: Vevey
country: Switzerland
facility: Global Medical Affairs, Société des Produits Nestlé
Study officials:
References:
citation: Storm HM, Shepard J, Czerkies LM, Kineman B, Cohen SS, Reichert H, Carvalho R. 2'-Fucosyllactose Is Well Tolerated in a 100% Whey, Partially Hydrolyzed Infant Formula With Bifidobacterium lactis: A Randomized Controlled Trial. Glob Pediatr Health. 2019 Mar 15;6:2333794X19833995. doi: 10.1177/2333794X19833995. eCollection 2019.