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Effect of Bifidobacterium administration on fecal IgA in full-term infants: a randomized control pilot trial

Effect of Bifidobacterium administration on fecal IgA in full-term infants: a randomized control pilot trial - Fecal IgA in full-term infants who take Bifidobacterium trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033295
Enrollment
100
Registered
2019-05-31
Start date
2018-03-07
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

normal birth-weight and full-term infant

Interventions

A group: The test formula is the infant formula containing heat-treated Bifidobacterim bifidum OLB6378 C group: The infant formula without Bifidobacterium bifidum OLB6378. It is indistinguishable from

Sponsors

Graduate School of Medicine, Chiba University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. normal birth-weight (2,500 g <= birth-weight < 4,000 g ) infant and his/her mother 2. full-term (37 weeks <= gestational age < 42 weeks) infant and his/her mother 3. Signed consent form to participate in the study was obtained from the infant's mother as the legal representative after full explanation of this study and its ethical considerations to persons in parental authority.

Exclusion criteria

Exclusion criteria: 1. infant with severe infection and his/her mother 2. infant with severe congenital abnormality and his/her mother 3. infant who is considered unsuitable subjects by the attending physician and his/her mother

Design outcomes

Primary

MeasureTime frame
Fecal IgA level of infants

Secondary

MeasureTime frame
The number of Bifidobacterium bifidum in infant feces Frequency of eczema in the study infants

Countries

Japan

Contacts

Public ContactHiroki Takayama

Soiken Inc. Clinical Study Support Division

takayama@soiken.com03-3295-1350

Outcome results

None listed

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