NCT01983072

Brief Summary

The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates and to allow a greater diversity of Bifidobacteria species in comparison with a formula non-supplemented with pre and probiotics.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for phase_2 healthy

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_2 healthy

Geographic Reach
2 countries

4 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

April 1, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

3.3 years

First QC Date

October 29, 2013

Last Update Submit

November 12, 2013

Conditions

Healthy

Keywords

colonization of the gastrointestinal tract with bacteria

Outcome Measures

Primary Outcomes (1)

  • stool bacterial populations

    (Lactobacilli, Clostridia, Bacteroides, bifidobacteria, staphylococci, Enterobacteria and Bifidobacterial species at 1.5 months and 3 months of age of the infants.

    3 months

Secondary Outcomes (3)

  • changes in weight

    3 months

  • Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)

    3 months

  • changes in length

    3 months

Study Arms (3)

Infant starter formula

ACTIVE COMPARATOR

standard infant formula

Dietary Supplement: Infant formula

Infant starter formula + prebiotics + probiotics

EXPERIMENTAL

infant formula

Dietary Supplement: Infant formula

Breastfeeding group

OTHER

reference group

Other: Breastfeeding

Interventions

Infant formulaDIETARY_SUPPLEMENT
Infant starter formulaInfant starter formula + prebiotics + probiotics
BreastfeedingOTHER

Breastfeeding

Breastfeeding group

Eligibility Criteria

AgeUp to 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy newborn infant
  • Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation)
  • Age of infant is between 14 days at the time of enrollment
  • Birth weight between 2500g and 4500g
  • For the Formula fed groups: The infant's mother has elected, before the 14th day of their child's life, not to continue breastfeeding (no breastfeeding after the 14th day of the child's life) For the Breastfed group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age
  • Having obtained his/her legal representative's informed consent

You may not qualify if:

  • Congenital illness or malformation that may affect normal growth
  • Significant pre-natal and/or post-natal disease
  • Re-hospitalization for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
  • Newborn who have received antibiotics during the first 14 days of life
  • Receiving infant formula containing pro and/or prebiotics at the time of enrolment
  • Newborn whose parents / caregivers cannot be expected to comply with treatment
  • Newborn currently participating in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital Saint Joseph

Marseille, 13008, France

Location

Hôpital de la Conception

Marseille, 13015, France

Location

Hôpital Nord

Marseille, 13015, France

Location

The Medical University of Warsaw

Warsaw, 01-184, Poland

Location

MeSH Terms

Interventions

Infant FormulaLactation

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and BeveragesReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Study Officials

  • Hania Szajewska

    The Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2013

First Posted

November 13, 2013

Study Start

April 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

FR(3)PL(1)