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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00835874
• Other study ID #: TASMC-06-SD-363-CTIL
• Status: Terminated
• Phase: N/A
• First received: July 5, 2007
• Last updated: August 1, 2012
• Start date: June 2007
• Est. completion date: July 2009

Study information

• Verified date: August 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Mothers of preterm infants

• Pumping breast milk

Exclusion Criteria:

• Neonatal congenital anomalies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis
• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality at three months of age		3 months	Yes
Primary	incidence and severity of necrotizing enterocolitis by Bell's staging at Three months		3 months	Yes
Primary	occurrence of bacterial or fungal infection per blood,csf or urine cultures at three months		3 months	Yes
Secondary	incidence of BPD, PVL, ROP		36 weeks	No
Secondary	maternal adverse effects during treatment		3 months	No