NCT03513744

Brief Summary

The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

November 19, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2021

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

2.3 years

First QC Date

April 12, 2018

Last Update Submit

October 13, 2023

Conditions

Infant Nutrition

Keywords

human milk oligosaccharidesinfant formula

Outcome Measures

Primary Outcomes (1)

  • assessment of body weight (in grams) of term infants

    growth, assessed by body weight gain, of term infants from enrollment to 4 month of life

    4 month

Secondary Outcomes (2)

  • assessment of body length (in centimeter) of term infants

    4 month

  • assessment of head circumference (in centimeter) of term infants

    4 month

Other Outcomes (7)

  • digestive tolerance

    4 month

  • influence of digestion

    4 month

  • influence on behaviour

    4 month

  • +4 more other outcomes

Study Arms (3)

infant formula containing five HMOs

EXPERIMENTAL
Dietary Supplement: human milk oligosaccharides

infant formula

NO INTERVENTION

breast milk group

NO INTERVENTION

Interventions

human milk oligosaccharidesDIETARY_SUPPLEMENT

mixture of five different human milk oligosaccharides

infant formula containing five HMOs

Eligibility Criteria

Age1 Day - 13 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Singleton birth
  • Full-term infant (37 - 42 weeks of gestational age)
  • APGAR score of 9 or 10
  • Birth weight 2500 - 4500 g

You may not qualify if:

  • clinically significant condition/ disorder
  • Adverse maternal of fetal medical history that may influence growth/development of the subject or tolerance of the infant formula
  • readmission to hospital (except for hyperbilirubinemia)
  • allergy to cow's milk
  • participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Facharzt für Kinder und Jugendmedizin

Mannheim, 68161, Germany

Location

Klinikum Südstadt Rostock

Rostock, 18059, Germany

Location

ASST Spedali Civili di Brescia - Presidio Ospedale dei Bambini

Brescia, 25123, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Hospital HM Puerta del Sur

Madrid, 28015, Spain

Location

Hospital HM Monteprincipe

Madrid, 28660, Spain

Location

Hospital HM Nuevo Belen

Madrid, 28938, Spain

Location

Hospital Universitario Sant Joan de Reus

Reus, 43204, Spain

Location

Hospital Joan XXII of Tarragona

Tarragona, 43005, Spain

Location

Study Officials

  • Frank Jochum, Dr. med.

    Universitaetsmedizin Berlin, Charité

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2018

First Posted

May 2, 2018

Study Start

November 19, 2018

Primary Completion

March 3, 2021

Study Completion

April 5, 2021

Last Updated

October 16, 2023

Record last verified: 2023-10

Locations

IT(2)DE(2)ES(5)