NCT00835874

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

2.1 years

First QC Date

July 5, 2007

Last Update Submit

August 1, 2012

Conditions

Necrotizing EnterocolitisSepsis

Keywords

probioticpretermlactationbreast feedingnecrotizing enterocolitissepsisbacterial cultureslactating motherbreast feeding of at least 50% of enteric feeding volumeInfant, very low birth weight

Outcome Measures

Primary Outcomes (3)

  • 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 (2)

  • incidence of BPD, PVL, ROP

    36 weeks

  • maternal adverse effects during treatment

    3 months

Interventions

ProbioticsDRUG

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers of preterm infants
  • Pumping breast milk

You may not qualify if:

  • Neonatal congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (1)

  • 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.

    PMID: 23934538DERIVED

MeSH Terms

Conditions

Enterocolitis, NecrotizingSepsisPremature BirthBreast Feeding

Interventions

Probiotics

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Shaul Dollberg

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR

  • Shira Benor

    Tel Aviv Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2007

First Posted

February 4, 2009

Study Start

June 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 2, 2012

Record last verified: 2012-08

Locations

IL(1)