Probiotics and Early Microbial Contact in Preterm Neonates

Not Applicable

• Conditions: Breastfeeding; Premature; Infant, Light-for-dates
• Interventions: Dietary Supplement: LGG; Dietary Supplement: LGG+Bb-12; Dietary Supplement: Placebo

• Registration Number: NCT01454661
• Lead Sponsor: Turku University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-14
• Study First Posted: 2011-10-19
• Study Start: 2014-04
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-19
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• premature infant born at <35 weeks gestational age

Exclusion Criteria

• severe asphyxia
• significant anomalies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LGG mother - placebo infant	LGG	The probiotic LGG is administered to the lactating mother whilst the infant receives placebo.
placebo mother - LGG infant	LGG	Placebo is administered to the lactating mother whilst the infant receives the probiotic LGG.
LGG+Bb-12 mother - Placebo infant	LGG+Bb-12	A combination of the probiotics LGG and Bb-12 is administered to the lactating mother, the infant receives placebo.
placebo mother - placebo infant	Placebo	Placebo is administered to both the lactating mother and her infant.
Pacebo mother - LGG+Bb-12 infant	LGG+Bb-12	Placebo is administered to the lactating mother, the infant receives a combination of the probiotics LGG and Bb-12

Primary Outcome Measures

Name	Time	Method
Gut microbiota	1 month	Assessment of indigenous intestinal microbiota composition in premature neonates during the first month of life

Secondary Outcome Measures

Name	Time	Method
Breast milk compostion	1 months	Immunological and microbiological properties of breast milk will be investigated.
Intestinal immunity	1 month	Intestinal immune gene expression profiles will be assessed from fecal samples.

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland