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Probiotic Administartion to Mothers of Preterm Infants to Prevent Necrotizing Enterocolitis and Sepsis

NCT ID: NCT00835874

Last Updated: 2012-08-02

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

TERMINATED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-07-31

Brief Summary

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We hypothesize that supplementing maternal diet with probiotics will decrease the incidence of feeding intolerance, necrotizing enterocolitis and sepsis in preterm infants fed breastmilk.

Detailed Description

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Oral probiotics have previously been shown to prevent necrotizing enterocolitis in preterm infants. A few reports of sepsis by a probiotic bacteria have impeded implementation of oral probiotic supplementation in most NICUs. Considering the proven immunomodulatory effect of maternal probiotics on breastfed infants of atopic mothers, we would like to explore the indirect effects of maternal probiotics on preterm infants

Conditions

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Necrotizing Enterocolitis Sepsis

Keywords

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probiotic preterm lactation breast feeding necrotizing enterocolitis sepsis bacterial cultures lactating mother breast feeding of at least 50% of enteric feeding volume Infant, very low birth weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Probiotics

Lactobacillus acidophilus, b.lactis capsule. Once daily.2X 10 by the power of 10 bacteria per dose.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mothers of preterm infants
* Pumping breast milk

Exclusion Criteria

* Neonatal congenital anomalies
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shaul Dollberg

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Shira Benor

Role: STUDY_DIRECTOR

Tel Aviv Medical Center

Locations

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Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

References

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Benor S, Marom R, Ben Tov A, Armoni Domany K, Zaidenberg-Israeli G, Dollberg S. Probiotic supplementation in mothers of very low birth weight infants. Am J Perinatol. 2014 Jun;31(6):497-504. doi: 10.1055/s-0033-1353490. Epub 2013 Aug 9.

Reference Type DERIVED
PMID: 23934538 (View on PubMed)

Other Identifiers

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TASMC-06-SD-363-CTIL

Identifier Type: -

Identifier Source: org_study_id