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The effect of Bifidobacterium breve on immunologic parameters in low birth weight infants:An Open-label non-randomized controlled trial

The effect of Bifidobacterium breve on immunologic parameters in low birth weight infants:An Open-label non-randomized controlled trial - The effect of Bifidobacterium breve on immunologic parameters in low birth weight infants:An Open-label non-randomized controlled trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016663
Enrollment
70
Registered
2015-02-28
Start date
2015-04-06
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

Infants born with birth weight equal to or greater than 1500g, and less than 2000g

Interventions

Bifidobacterium breve M-16V will be dissolved in water and amout of 0.5ml will be given within 24 hours after birth. The infants will receive probiotics once a day, for 21 days. No application

Sponsors

Tokyo Metropolitan Childrens'medical center, department of Neonatology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Infants whose birth weight is equal to or greater than 1500g and less than 2000g, who were admitted to our hospital within 21 hours after birth.

Exclusion criteria

Exclusion criteria: Newborns with chromosomal anomaly, multiple congenital anomaly, congenital heart disease, congenital anomaly of intestine, and those who were judged inappropriate by the principal investigator

Design outcomes

Primary

MeasureTime frame
evaluate the fecal calprotectin concentration at day7 and day21.

Secondary

MeasureTime frame
Evaluate the composition of intestinal flora on day0, 7, 21. Immunologic parameters such as fecal IgA concentration, serum cytokines, serum high sensitive CRP will be checked on day7 and 21. Body weight and feeding intolerance will be checked every day until day21.

Countries

Japan

Contacts

Public ContactYuki Kimura

Tokyo Metropolitan Childrens'medical center Neonatology

yuki_kimura@tmhp.jp042-300-5111

Outcome results

None listed

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