Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00835874

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

No publications provided by Tel-Aviv Sourasky Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov 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
Health Authority: Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
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

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Sepsis
Toxemia
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Infection
Inflammation
Intestinal Diseases
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 25, 2014