Bifidobacterium Supplementation for Very Low Birth Weight Infants

Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01375309

Acronym

Bifido(RCT)

Enrollment

246

Registered

2011-06-17

Start date

2010-01-31

Completion date

2011-12-31

Last updated

2012-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infants

Keywords

probiotics, preterm infants, enteral feeding, Bifidobacterium on enteral feeding

Brief 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.

Interventions

DIETARY_SUPPLEMENTBifidobacterium bifidum supplementation

Bifidobacterium bifidum supplementation wiht approximately 2.5\*10to9th bacteria per day

DIETARY_SUPPLEMENTPlacebo contains dextrin

0.5 of dextrin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 48 Hours

Healthy volunteers

Inclusion criteria

* Infants with birth weight less than 1500g

Exclusion criteria

* Sever bacteremia * Congenital anomaly * Not suitable for the trial defined by an attending neonatologist

Design outcomes

Primary

Measure	Time frame	Description
Postnatal day when enteral feeding exceeded at 100ml/kg/day	From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth	Death or unsuccessful of establishing enteral feeding exceeded at 100ml/kg/day before day 28 of age is considered failure to reach primary endpoint.

Secondary

Measure	Time frame	Description
standard deviation(SD) scores of bodyweight(BW) and head circumference(HC)	For the duration of NICU stay, an expected average of 3 months	BW gain/day, SD scores of BW and HC at discharge from NICU
Necrotizing enterocolitis or sepsis	For the duration of NICU stay, an expected average of 3 months	The incidences of necrtizing enterocolitis or sepsis during the stay in NICU
Intestinal flora	For the duration of NICU stay, an expected average of 3 months	Intestinal flora during the stay in NICU

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026