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Probiotics and Early Microbial Contact in Preterm Neonates

Probiotic Modulation of Early Microbial Contact in Premature Infants

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01454661
Acronym
ProPre
Enrollment
100
Registered
2011-10-19
Start date
2014-04-30
Completion date
2019-04-30
Last updated
2018-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature; Infant, Light-for-dates, Breastfeeding

Keywords

Probiotics, Premature infant, Intestinal microbiota, Intestinal immunity, Breastfeeding

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: 1. 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. 2. 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. 3. To elucidate the impact probiotic bacteria administered to the lactating mother and/or directly to the infant on gut immunophysiology in preterm infants.

Interventions

DIETARY_SUPPLEMENTLGG

Lactobacillus rhamnosus GG 10E9 cfu / day

DIETARY_SUPPLEMENTLGG+Bb-12

A combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12 administered 10E9 cfu / day each.

DIETARY_SUPPLEMENTPlacebo

Microcrystalline cellulose is used as placebo.

Sponsors

University of Turku
CollaboratorOTHER
Massachusetts General Hospital
CollaboratorOTHER
Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
Yes

Inclusion criteria

* premature infant born at \<35 weeks gestational age

Exclusion criteria

* severe asphyxia * significant anomalies

Design outcomes

Primary

MeasureTime frameDescription
Gut microbiota1 monthAssessment of indigenous intestinal microbiota composition in premature neonates during the first month of life

Secondary

MeasureTime frameDescription
Intestinal immunity1 monthIntestinal immune gene expression profiles will be assessed from fecal samples.
Breast milk compostion1 monthsImmunological and microbiological properties of breast milk will be investigated.

Countries

Finland

Contacts

Primary ContactSamuli Rautava, MD, PhD
samrau@utu.fi+358 40 7033166

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026