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

Zekai Tahir Burak Women's Health Research and Education Hospital

Status and phase: Completed; Phase 4

Conditions: Very Low Birth Weight Infants

Treatments: Dietary Supplement: Lactobacillus reuteri; Drug: Nystatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01531192

ZTB630301

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 1 day to 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

300 participants in 2 patient groups

Lactobacillus reuteri

Experimental group

Description:

Lactobacillus reuteri 100 million CFU/day for 3 months

Treatment:

Dietary Supplement: Lactobacillus reuteri

Nystatin

Active Comparator group

Description:

50000 unit/3 times a day

Treatment:

Drug: Nystatin