Human Milk Oligosaccharides (HMOs) Post-market Study on Infants (NEHMO)

NCT ID: NCT05150288

Last Updated: 2021-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-08
• Study Completion Date: 2020-07-24

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

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Formula-fed infants

Infants fed exclusively with experimental formula

Group Type: EXPERIMENTAL

HMO-supplemented infant formula

Intervention Type: OTHER

Starter Infant Formula supplemented with 1.5g/L of Human Milk Oligosaccharides

Mixed-fed infants

Infants receiving breastmilk and experimental formula

Group Type: EXPERIMENTAL

HMO-supplemented infant formula

Intervention Type: OTHER

Starter Infant Formula supplemented with 1.5g/L of Human Milk Oligosaccharides

Breast-fed infants

Reference group of exclusively breastfed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HMO-supplemented infant formula

Starter Infant Formula supplemented with 1.5g/L of Human Milk Oligosaccharides

Intervention Type: OTHER

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

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 2 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Waldkrankenhaus Protestant Hospital, Spandau

OTHER

Sponsor Role: collaborator

Kinderarztpraxis Köllges, Mossakowski und Meyer-Krott, Mönchengladbach

UNKNOWN

Sponsor Role: collaborator

Gemeinschaftspraxis Kinder- und Jugendpraxis Dr. Stepan Dreher und Tina Hübler, Geldern

UNKNOWN

Sponsor Role: collaborator

Kinder- und Jugendarzt Dr. Umpfenbach und Dr. Lorenz, Viersen

UNKNOWN

Sponsor Role: collaborator

Kinder- und Jugendärztliche Gemeinschaftspraxis Bedikian & Bouikidis, Oberhausen

UNKNOWN

Sponsor Role: collaborator

Kinderarztpraxis Dr. Zakarian, Düsseldorf

UNKNOWN

Sponsor Role: collaborator

Facharztpraxis für Kinder- und Jugendmedizin Dr. Aulinger, Burglengenfeld

UNKNOWN

Sponsor Role: collaborator

Zentrum für Kinder- und Jugendgesundheit Regensburg

UNKNOWN

Sponsor Role: collaborator

Kinder- und Jugendarztpraxis Schwabach

UNKNOWN

Sponsor Role: collaborator

Praxis Dr. Klee, Bürstadt

UNKNOWN

Sponsor Role: collaborator

Facharzt für Säuglings-, Kinder- und Jugendmedizin, Bremen

UNKNOWN

Sponsor Role: collaborator

Praxis Al-Radhi, Ehingen

UNKNOWN

Sponsor Role: collaborator

Kinder und Jugendarztpraxis Dr. Maier, Leinfelden-Echterdingen

UNKNOWN

Sponsor Role: collaborator

Kinder- und Jugendarztpraxis Dr. Kröckel, Dr. Ciesla, Berlin

UNKNOWN

Sponsor Role: collaborator

Facharzt für Kinder- und Jugendheilkunde Dr. Faustmann, Oberwart

UNKNOWN

Sponsor Role: collaborator

Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland

UNKNOWN

Sponsor Role: collaborator

Global Medical Affairs, Société des Produits Nestlé S.A., Vevey, Switzerland

UNKNOWN

Sponsor Role: collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Facharzt für Kinder- und Jugendheilkunde

Oberwart, , Austria

Kinder- und Jugensarztpraxis

Berlin, , Germany

Evangelisches Waldkrankenhaus Spandau

Berlin-Spandau, , Germany

Facharzt für Säuglings-, Kinder- und Jugendmedizin

Bremen, , Germany

Facharztpraxis für Kinder- und Jugendmedizin

Burglengenfeld, , Germany

Praxis Dr. Klee

Bürstadt, , Germany

Kinderarztpraxis

Düsseldorf, , Germany

Praxis Al-Radhi

Ehingen, , Germany

Gemeinschaftspraxis Kinder- und Jugendarztpraxis

Guelders, , Germany

Kinder und Jugendarztpraxis

Leinfelden-Echterdingen, , Germany

Kinderarztpraxis Köllges

Mönchengladbach, , Germany

Kinder- und Jugendärztliche Gemeinschaftspraxis

Oberhausen, , Germany

Zentrum für Kinder- und Jugendgesundheit

Regensburg, , Germany

Kinder- und Jugendarztpraxis

Schwabach, , Germany

Kinder- und Jugendarzt

Viersen, , Germany

Nestlé Research, Société des Produits Nestlé S.A.

Lausanne, , Switzerland

Global Medical Affairs, Société des Produits Nestlé

Vevey, , Switzerland

Countries

Austria; Germany; Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 30906817 (View on PubMed)

Other Identifiers

1806INF- DACH

Identifier Type: -

Identifier Source: org_study_id