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Probiotics and Early Microbial Contact in Preterm Neonates (ProPre)

Primary Purpose

Premature; Infant, Light-for-dates, Breastfeeding

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
LGG
LGG+Bb-12
Placebo
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Premature; Infant, Light-for-dates focused on measuring Probiotics, Premature infant, Intestinal microbiota, Intestinal immunity, Breastfeeding

Eligibility Criteria

undefined - 3 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • premature infant born at <35 weeks gestational age

Exclusion Criteria:

  • severe asphyxia
  • significant anomalies

Sites / Locations

  • Turku University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

placebo mother - LGG infant

placebo mother - placebo infant

LGG mother - placebo infant

LGG+Bb-12 mother - Placebo infant

Pacebo mother - LGG+Bb-12 infant

Arm Description

Placebo is administered to the lactating mother whilst the infant receives the probiotic LGG.

Placebo is administered to both the lactating mother and her infant.

The probiotic LGG is administered to the lactating mother whilst the infant receives placebo.

A combination of the probiotics LGG and Bb-12 is administered to the lactating mother, the infant receives placebo.

Placebo is administered to the lactating mother, the infant receives a combination of the probiotics LGG and Bb-12

Outcomes

Primary Outcome Measures

Gut microbiota
Assessment of indigenous intestinal microbiota composition in premature neonates during the first month of life

Secondary Outcome Measures

Intestinal immunity
Intestinal immune gene expression profiles will be assessed from fecal samples.
Breast milk compostion
Immunological and microbiological properties of breast milk will be investigated.

Full Information

First Posted
October 10, 2011
Last Updated
April 18, 2018
Sponsor
Turku University Hospital
Collaborators
University of Turku, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01454661
Brief Title
Probiotics and Early Microbial Contact in Preterm Neonates
Acronym
ProPre
Official Title
Probiotic Modulation of Early Microbial Contact in Premature Infants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
University of Turku, Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Probiotics are live microbes which, when administered in sufficient amounts, confer a health benefit to the host. According to recent clinical trials, administration of probiotics to very low birth weight infants significantly reduces overall mortality and risk of necrotizing enterocolitis, a devastating inflammatory intestinal disease. The investigators have previously demonstrated that administering probiotics to the lactating mother enhances the immunoprotective properties of breast milk. Despite the promising data, the optimal probiotic intervention is yet to be established. The mechanisms by which probiotics exert their effects remain largely unknown. This research project is based on the notion that modulation of early microbial contact by probiotics may provide a safe and effective means to improve the health of preterm infants. In particular, the investigators hypothesize that the protective potential of probiotics may be enhanced via breast milk by administering probiotics to the lactating mother. All of the potentially beneficial effects of probiotic bacteria are strain-specific and therefore preliminary laboratory and clinical research with regard to different physiological targets of probiotic intervention should be carried out to guide the design of large-scale clinical trials aiming show clinical efficacy and establish clinical practice. The purpose of this research project is to identify targets for probiotic therapy in premature neonates and to provide insight into the optimal probiotic strains and administration protocol the clinical efficacy of which will subsequently be tested in a randomized controlled trial. The specific aims of the project are: To determine the effect of maternal consumption of probiotics during lactation on immunomodulatory properties of breast milk in mothers of premature infants. Concentrations of immunomodulatory factors and microbiological properties of breast milk will be measured. To investigate the impact of different probiotic administration protocols on gut microbiota composition in preterm infants. In particular, the issue whether maternal probiotic consumption instead or in addition to probiotics administered to the infant is effective will be elucidated. Different potential probiotic strains will be assessed. To elucidate the impact probiotic bacteria administered to the lactating mother and/or directly to the infant on gut immunophysiology in preterm infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature; Infant, Light-for-dates, Breastfeeding
Keywords
Probiotics, Premature infant, Intestinal microbiota, Intestinal immunity, Breastfeeding

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo mother - LGG infant
Arm Type
Active Comparator
Arm Description
Placebo is administered to the lactating mother whilst the infant receives the probiotic LGG.
Arm Title
placebo mother - placebo infant
Arm Type
Placebo Comparator
Arm Description
Placebo is administered to both the lactating mother and her infant.
Arm Title
LGG mother - placebo infant
Arm Type
Active Comparator
Arm Description
The probiotic LGG is administered to the lactating mother whilst the infant receives placebo.
Arm Title
LGG+Bb-12 mother - Placebo infant
Arm Type
Active Comparator
Arm Description
A combination of the probiotics LGG and Bb-12 is administered to the lactating mother, the infant receives placebo.
Arm Title
Pacebo mother - LGG+Bb-12 infant
Arm Type
Active Comparator
Arm Description
Placebo is administered to the lactating mother, the infant receives a combination of the probiotics LGG and Bb-12
Intervention Type
Dietary Supplement
Intervention Name(s)
LGG
Intervention Description
Lactobacillus rhamnosus GG 10E9 cfu / day
Intervention Type
Dietary Supplement
Intervention Name(s)
LGG+Bb-12
Intervention Description
A combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12 administered 10E9 cfu / day each.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Microcrystalline cellulose is used as placebo.
Primary Outcome Measure Information:
Title
Gut microbiota
Description
Assessment of indigenous intestinal microbiota composition in premature neonates during the first month of life
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Intestinal immunity
Description
Intestinal immune gene expression profiles will be assessed from fecal samples.
Time Frame
1 month
Title
Breast milk compostion
Description
Immunological and microbiological properties of breast milk will be investigated.
Time Frame
1 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: premature infant born at <35 weeks gestational age Exclusion Criteria: severe asphyxia significant anomalies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuli Rautava, MD, PhD
Phone
+358 40 7033166
Email
samrau@utu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuli Rautava, MD, PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuli Rautava, MD, PhD
Phone
+358 40 7033166
Email
samrau@utu.fi

12. IPD Sharing Statement

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Probiotics and Early Microbial Contact in Preterm Neonates

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