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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00835874
Recruitment Status : Terminated (Difficulty in recruitment. Mothers of infants preferred to take probiotics bought over-the-counter over the possibility of being in a placebo group)
First Posted : February 4, 2009
Last Update Posted : August 2, 2012
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Necrotizing Enterocolitis Sepsis Drug: Probiotics Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Probiotic Administartion to Mothers of Preterm Infants to Prevent Necrotizing Enterocolitis and Sepsis
Study Start Date : June 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Intervention Details:
    Drug: Probiotics
    Lactobacillus acidophilus, b.lactis capsule. Once daily.2X 10 by the power of 10 bacteria per dose.

Primary Outcome Measures :
  1. all cause mortality at three months of age [ Time Frame: 3 months ]
  2. incidence and severity of necrotizing enterocolitis by Bell's staging at Three months [ Time Frame: 3 months ]
  3. occurrence of bacterial or fungal infection per blood,csf or urine cultures at three months [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. incidence of BPD, PVL, ROP [ Time Frame: 36 weeks ]
  2. maternal adverse effects during treatment [ Time Frame: 3 months ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mothers of preterm infants
  • Pumping breast milk

Exclusion Criteria:

  • Neonatal congenital anomalies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00835874

Tel Aviv Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Shaul Dollberg Tel Aviv Medical Center
Study Director: Shira Benor Tel Aviv Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tel-Aviv Sourasky Medical Center Identifier: NCT00835874     History of Changes
Other Study ID Numbers: TASMC-06-SD-363-CTIL
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012

Keywords provided by Tel-Aviv Sourasky Medical Center:
breast feeding
necrotizing enterocolitis
bacterial cultures
lactating mother
breast feeding of at least 50% of enteric feeding volume
Infant, very low birth weight

Additional relevant MeSH terms:
Enterocolitis, Necrotizing
Systemic Inflammatory Response Syndrome
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases