NCT04306263

Brief Summary

The purpose of this study is to test whether the addition of certain bioactive ingredients to a new infant formula (HMOs, osteopontin and probiotics) can have a favorable impact on the development of the infant's immune system in the first months of life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 2, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

2.5 years

First QC Date

March 2, 2020

Last Update Submit

December 14, 2020

Conditions

Infant Growth

Outcome Measures

Primary Outcomes (3)

  • Register of infections

    Register of infant infections through patient diaries completed by parents

    From baseline to 12 months

  • Register of fever episodes

    Presence and duration of the fever and treatments, through diaries completed by parents

    From baseline to 12 months.

  • Register of diarrhea episodes

    Presence and duration of diarrhea, registered in patients dairies.

    From baseline to 12 months.

Secondary Outcomes (10)

  • Immune response evaluation

    At 3, 6 and 12 months of age

  • Demographic data

    From baseline to 12 months.

  • Obstetric background

    Baseline

  • Study of the infant microbiota

    At 3, 6 and 12 months.

  • Assessment of normal growth of the infant

    From baseline to 12 months.

  • +5 more secondary outcomes

Study Arms (3)

Enriched infant formula

EXPERIMENTAL

Infant formula enriched with dairy ingredients: osteopontin, prebiotics (Human milk oligosaccharide, Glucooligosaccharides) and probiotics.

Dietary Supplement: Enriched infant formula

Standard formula

ACTIVE COMPARATOR

Infants receiving a standard infant formula.

Dietary Supplement: Standard formula

Breastfeeding arm

ACTIVE COMPARATOR

Infants exclusively or predominantly breastfed (\>75%).

Dietary Supplement: Breastfeeding arm

Interventions

Enriched infant formulaDIETARY_SUPPLEMENT

Infant formula enriched with dairy ingredients: osteopontin, prebiotics and probiotics

Enriched infant formula
Standard formulaDIETARY_SUPPLEMENT

Infants receiving a standard infant formula.

Standard formula
Breastfeeding armDIETARY_SUPPLEMENT

Infants exclusively or predominantly breastfed (\>75%).

Breastfeeding arm

Eligibility Criteria

AgeUp to 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age \>37 weeks and \<41 weeks inclusive.
  • Appropriate birth weight appropriate for your gestational age (between 10-90 percentiles).
  • APGAR score normal birth to 1' and 5' of 7 - 10.
  • Umbilical pH ≥ 7.10.
  • Availability to continue throughout the study period.
  • Written informed consent
  • Infants who, at the time of recruitment, have already passed the diet with a majority or exclusive formula for medical reasons, by decision of the parents or any other reason agreed with the pediatrician.
  • Infants who have been breastfed until the second month with exclusive or majority breastfeeding.
  • Infants who are expected to be exclusively or predominantly breastfed up to 6 months.

You may not qualify if:

  • Simultaneous participation in other clinical trials.
  • Infants suffering from gastrointestinal disorders (allergy and/or intolerance to cow's milk protein or lactose).
  • Mother's pathology history and during gestation: neurological diseases, metabolic disorders, type 1 diabetes mellitus, chronic disease (hypothyroidism), maternal malnutrition, TORCH syndrome.
  • Treatment of the mother's anxiolytics or antidepressants. Other treatments with drugs potentially harmful to neurodevelopment.
  • Inability of the parents to follow up the study (medical decision).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cristina Campoy

Granada, Andalusia, 18016, Spain

RECRUITING

Study Officials

  • Cristina Campoy, MD

    EURISTIKOS Excellence Centre for Paediatric Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roser De Castellar, MD

CONTACT

902 10 52 43roser.decastellar@ordesa.es

Cristina Campoy, MD

CONTACT

+34629308695ccampoy@ugr.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 12, 2020

Study Start

March 2, 2020

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations

ES(1)