Efficacy of early administration of BBG-01 (Bifidobacterium breve) on growth and development of preterm infants in NICU

Efficacy of early administration of BBG-01 (Bifidobacterium breve) on growth and development of preterm infants in NICU - Efficacy of BBG-01 administration for preterm infants

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005412

Enrollment

200

Registered

2011-04-08

Start date

2011-04-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

very low birth weight (VLBW) infants and extremely low birth weight (ELBW) infants

Interventions

Bifidobacterium breve Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: VLBW infants and ELBW infants

Exclusion criteria

Exclusion criteria: A lethal congenital abnormality known at trial entry. Any known gastrointestinal malformation. No realistic prospect of survival.

Design outcomes

Primary

Measure	Time frame
Body weight, height, head circumference, vital sign	—

Secondary

Measure	Time frame
Fatty acids in blood Intestinal microbiota and intestinal environment	—

Countries

Japan

Contacts

Public ContactYuichiro Yamashiro

Juntendo University, Division of Laboratory for Probiotic Research

03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026