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

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.

Conditions

• Growth
• Tolerance
• Adverse Event
• Disorder of Intestine
• Formula Satisfaction

Interventions

OTHER

HMO-supplemented infant formula

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

Sponsors & Collaborators

• Waldkrankenhaus Protestant Hospital, Spandau

  collaborator OTHER

• Kinderarztpraxis Köllges, Mossakowski und Meyer-Krott, Mönchengladbach

  collaborator UNKNOWN

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

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Kinder- und Jugendärztliche Gemeinschaftspraxis Bedikian & Bouikidis, Oberhausen

  collaborator UNKNOWN

• Kinderarztpraxis Dr. Zakarian, Düsseldorf

  collaborator UNKNOWN

• Facharztpraxis für Kinder- und Jugendmedizin Dr. Aulinger, Burglengenfeld

  collaborator UNKNOWN

• Zentrum für Kinder- und Jugendgesundheit Regensburg

  collaborator UNKNOWN

• Kinder- und Jugendarztpraxis Schwabach

  collaborator UNKNOWN

• Praxis Dr. Klee, Bürstadt

  collaborator UNKNOWN

• Facharzt für Säuglings-, Kinder- und Jugendmedizin, Bremen

  collaborator UNKNOWN

• Praxis Al-Radhi, Ehingen

  collaborator UNKNOWN

• Kinder und Jugendarztpraxis Dr. Maier, Leinfelden-Echterdingen

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Facharzt für Kinder- und Jugendheilkunde Dr. Faustmann, Oberwart

  collaborator UNKNOWN

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

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Société des Produits Nestlé (SPN)

  lead INDUSTRY

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Days

Max Age

2 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-08

Primary Completion

2020-07-24

Completion

2020-07-24

Countries

• Austria
• Germany
• Switzerland

Study Locations