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Symbiotic & Colonization

NCT ID: NCT01983072

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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The infants will be recruited and randomized between 0 and 14 days. The intervention period, in terms of data necessary for the primary outcome, will be until they reach 3 months old. Measurements will be collected on three separate occasions during this period, i.e. 2 and 6 weeks and 3 months. Stools will be collected, on 3 separate occasions, i.e. 4-5 day, 6 weeks and 3 months of life.

Conditions

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Healthy

Keywords

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colonization of the gastrointestinal tract with bacteria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Infant starter formula

standard infant formula

Group Type ACTIVE_COMPARATOR

Infant formula

Intervention Type DIETARY_SUPPLEMENT

Infant starter formula + prebiotics + probiotics

infant formula

Group Type EXPERIMENTAL

Infant formula

Intervention Type DIETARY_SUPPLEMENT

Breastfeeding group

reference group

Group Type OTHER

Breastfeeding

Intervention Type OTHER

Breastfeeding

Interventions

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Infant formula

Intervention Type DIETARY_SUPPLEMENT

Breastfeeding

Breastfeeding

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hania Szajewska

Role: PRINCIPAL_INVESTIGATOR

The Medical University of Warsaw

Locations

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Hôpital Saint Joseph

Marseille, , France

Site Status

Hôpital de la Conception

Marseille, , France

Site Status

Hôpital Nord

Marseille, , France

Site Status

The Medical University of Warsaw

Warsaw, , Poland

Site Status

Countries

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France Poland

Other Identifiers

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06.08.INF

Identifier Type: -

Identifier Source: org_study_id