Safety and Effect of Bifidobacterium breve M-16V Supplementation to sick infants.

Safety and Effect of Bifidobacterium breve M-16V Supplementation to sick infants. - Safety and Effect of Bifidobacterium breve M-16V.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015742

Enrollment

300

Registered

2014-12-01

Start date

2014-12-01

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

sick infants

Interventions

The NCU doctors instruct to administer Bifidobacteria breve (M-16V) to the registered infants. Control(non-adiministration) group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All the sick infants who are hospitalized in NCU amongthe newborn infants born in NMCHC.

Exclusion criteria

Exclusion criteria: the infants who already have caused gastrointestinal bleeding etc. and are considered to be unsuitable for administration of bifidobacterium into the stomach

Design outcomes

Primary

Measure	Time frame
A significant increase is not observed in the incidence of adverse events in the two groups of comparison administration group and non-administration group.	—

Countries

Asia(except Japan)

Contacts

Public ContactShinichi Hosokawa

National Center for Global Health and Medicine Pediatrics

shosokaw@hosp.ncgm.go.jp03-3202-7181

Outcome results

None listed

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