Probiotic Administartion to Mothers of Preterm Infants to... | NCT00835874

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

NCT00835874

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Terminated

Last Update Posted

Aug 2, 2012Estimated

Enrollment

57Actual

Phase

Not Applicable

Conditions

Necrotizing Enterocolitis
Sepsis

Interventions

Probiotics

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jul 5, 2007

First Submission Date that Met QC Criteria

Feb 3, 2009

First Posted Date

Feb 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2012

Last Update Posted Date

Aug 2, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Conditions Module

Conditions

Necrotizing Enterocolitis
Sepsis

Keywords

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotics	Drug	Lactobacillus acidophilus, b.lactis capsule. Once daily.2X 10 by the power of 10 bacteria per dose.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all cause mortality at three months of age		3 months
incidence and severity of necrotizing enterocolitis by Bell's staging at Three months		3 months
occurrence of bacterial or fungal infection per blood,csf or urine cultures at three months		3 months

Secondary Outcomes

Measure	Description	Time Frame
incidence of BPD, PVL, ROP		36 weeks
maternal adverse effects during treatment		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mothers of preterm infants
Pumping breast milk

Exclusion Criteria:

Neonatal congenital anomalies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shaul Dollberg	Tel Aviv Medical Center	Principal Investigator
Shira Benor	Tel Aviv Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel Aviv Medical Center		Tel Aviv		64239	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23934538	Derived	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.

ID	Term
D020345	Enterocolitis, Necrotizing
D018805	Sepsis
D047928	Premature Birth
D001942	Breast Feeding

ID	Term
D004760	Enterocolitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena