NCT04441359

Brief Summary

The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
2 countries

8 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

Study Start

First participant enrolled

June 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2010

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

2.4 years

First QC Date

June 10, 2020

Last Update Submit

June 18, 2020

Conditions

InfectionMicrobial ColonizationHealthy

Outcome Measures

Primary Outcomes (1)

  • Incidence of infections during first year of life

    measured through presence of fever, and number and duration of infectious episodes

    until infant reaches age of 1 year

Secondary Outcomes (12)

  • Stool frequency

    until infant reaches age of 1 year

  • Stool consistency

    until infant reaches age of 1 year

  • Digestive tolerance

    until infant reaches age of 1 year

  • Growth

    until infant reaches age of 1 year

  • Body weight

    until infant reaches age of 1 year

  • +7 more secondary outcomes

Study Arms (2)

supplemented formula

EXPERIMENTAL

Standard formula supplemented with prebiotic inulin-type fructans

Other: Supplemented formula

standard formula

PLACEBO COMPARATOR

Standard Formula not supplemented with prebiotic inulin-type fructans

Other: Standard formula

Interventions

Supplemented formulaOTHER

standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans

supplemented formula
Standard formulaOTHER

standard infant formula not supplemented with prebiotic inulin-type fructans

standard formula

Eligibility Criteria

Age1 Day - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy babies born between 37 - 42 weeks of gestation and with weight appropriate for gestational age (between percentiles 3 and 97)
  • Healthy babies aged between 0 - 4 months of age
  • Babies exclusively fed with an infant formula on enrolment into the study

You may not qualify if:

  • The presence of an infection at the moment of the recruitment or 1 week before recruitment
  • The presence of important pathologies (intestinal, cardiopathy, mental retardation, etc.)
  • Any other diseases related to the immune system (primary immunodeficiency)
  • Parents not able to comply with the study follow up (according to physician criteria)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

ZNA Koningin Paola Kinderziekenhuis

Antwerp, Belgium

Location

Universitair Ziekenhuis

Brussels, Belgium

Location

CAP Llefià

Barcelona, Spain

Location

Hospital de Nens

Barcelona, Spain

Location

Hospital Sant Joan de Deu

Barcelona, Spain

Location

University Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital San Cecilio

Granada, Spain

Location

Equipo Pediátrico San Francisco

Madrid, Spain

Location

Related Publications (1)

  • Rodriguez-Palmero, M.; Campoy, C.; Urraca, O.; Alonso, J.; Maldonado, J.; Varea, V.; Palencia, J.; Veereman-Wauters, G.; Neumer, F.; Rivero, M.; Vandenplas, Y. Effects of long-term supplementation with a mixture of short and long chain inulin-type oligosaccharides (2013), Annals of Nutrition and Metabolism, suppl. 1, (63), 1-1960.

    RESULT

MeSH Terms

Conditions

InfectionsCommunicable Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 22, 2020

Study Start

June 1, 2008

Primary Completion

October 31, 2010

Study Completion

October 31, 2010

Last Updated

June 22, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)ES(6)