Trials / Completed
CompletedNCT01375309
Bifidobacterium Supplementation for Very Low Birth Weight Infants
Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 246 (actual)
- Sponsor
- Tokyo Women's Medical University · Academic / Other
- Sex
- All
- Age
- 48 Hours
- Healthy volunteers
- Not accepted
Summary
Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Bifidobacterium bifidum supplementation | Bifidobacterium bifidum supplementation wiht approximately 2.5\*10to9th bacteria per day |
| DIETARY_SUPPLEMENT | Placebo contains dextrin | 0.5 of dextrin |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2011-06-01
- Completion
- 2011-12-01
- First posted
- 2011-06-17
- Last updated
- 2012-03-30
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01375309. Inclusion in this directory is not an endorsement.