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

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
• Disorder Lung

Interventions

OTHER

HMO-supplemented infant formula

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

Sponsors & Collaborators

• Puerta de Hierro University Hospital

  collaborator OTHER

• University of Navarrra Hospital (Clinica Universitaria)

  collaborator OTHER

• Grupo Pulso

  collaborator INDUSTRY

• Casa de la Salud Hospital

  collaborator UNKNOWN

• Vitha Santa Catalina Hospital

  collaborator UNKNOWN

• Quirón-Dexeus Universitary Hospital

  collaborator UNKNOWN

• Hospital Ruber Internacional

  collaborator OTHER

• Grupo Hispalense de Pediatría Hospital

  collaborator UNKNOWN

• MH Belén Maternal Hospital

  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

2018-10-01

Primary Completion

2018-11-30

Completion

2018-12-31

Countries

• Spain

Study Locations