Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

Very Low Birth Weight Infants Clinical Trial

Official title:

Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531192
• Other study ID #: ZTB630301
• Status: Completed
• Phase: Phase 4
• First received: February 4, 2012
• Last updated: July 13, 2013
• Start date: June 2012
• Est. completion date: April 2013

Study information

• Verified date: February 2012
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic Lactobacillus reuteri in reducing the candida colonization and infection in very low birth weight infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Very low birth weight infants < 1500 gr

• Gestational age < 32 weeks

Exclusion Criteria:

• Genetic anomalies

• Short bowel syndrome

• Not willing to participate

• Allergy to Lactobacillus reuteri components

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Very Low Birth Weight Infants

Intervention

Dietary Supplement:
• Lactobacillus reuteri
Lactobacillus reuteri 100 million CFU/day for 3 months

Drug:
• Nystatin
50000 unit/3 times a day, both for orally and by orogastric route

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants	Rectal and skin swabs for Candida colonization will be taken weekly. Blood culture for Candida infection will be taken weekly.	up to 6 months	Yes
Secondary	Effect of Lactobacillus reuteri on feeding intolerance	Feeding intolerance (gastric residuals in the amount that was more than half of the previous feeding, abdominal distention or heme-positive stools)	up to 6 months	Yes
Secondary	Effect of Lactobacillus reuteri on sepsis	Patients with culture positivity will accept as proven sepsis.	up to 6 months	Yes
Secondary	Effect of Lactobacillus reuteri on length of hospital stay	Specified length of hospital stay as days.	up to 6 months	Yes
Secondary	Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants	NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.	up to 6 months	No

External Links

•   Lactobacillus reuteri
•   Nystatin