This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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)
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center Identifier:
First received: July 5, 2007
Last updated: August 1, 2012
Last verified: August 2012
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 Intervention
Necrotizing Enterocolitis Sepsis Drug: Probiotics

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Tel-Aviv Sourasky Medical Center:

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

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

Enrollment: 57
Study Start Date: June 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Probiotics
    Lactobacillus acidophilus, b.lactis capsule. Once daily.2X 10 by the power of 10 bacteria per dose.
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: July 5, 2007
Last Updated: August 1, 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 processed this record on August 18, 2017