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

This study has been terminated.

(Difficulty in recruitment. Mothers of infants preferred to take probiotics bought over-the-counter over the possibility of being in a placebo group)

Sponsor:

Information provided by (Responsible Party):

Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT00835874

First received: July 5, 2007

Last updated: August 1, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 5, 2007

Last Updated Date

August 1, 2012

Start Date ^ICMJE

June 2007

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

all cause mortality at three months of age [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
incidence and severity of necrotizing enterocolitis by Bell's staging at Three months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
occurrence of bacterial or fungal infection per blood,csf or urine cultures at three months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00835874 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

incidence of BPD, PVL, ROP [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
maternal adverse effects during treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Necrotizing Enterocolitis
Sepsis

Intervention ^ICMJE

Drug: Probiotics

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Mothers of preterm infants
Pumping breast milk

Exclusion Criteria:

Neonatal congenital anomalies

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00835874

Other Study ID Numbers ^ICMJE

TASMC-06-SD-363-CTIL

Has Data Monitoring Committee

Responsible Party

Tel-Aviv Sourasky Medical Center

Study Sponsor ^ICMJE

Tel-Aviv Sourasky Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Shaul Dollberg	Tel Aviv Medical Center
Study Director:	Shira Benor	Tel Aviv Medical Center

Information Provided By

Tel-Aviv Sourasky Medical Center

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top