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Effects of probiotics in healthy infants: a randomized control trail

Effects of probiotics in healthy infants: a randomized, double-blind, placebo-controlled study - Effects of probiotics in healthy infants: a randomized, double-blind, placebo-controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038351
Enrollment
150
Registered
2019-10-23
Start date
2019-10-23
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

Healthy infants

Interventions

Ingestion of probiotics to healthy infants from registration to 3 month s after birth. Ingestion of placebo to healthy infants from registration to 3 month s after birth.

Sponsors

Matsumoto City Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) healthy full-term infants within 7 days after birth 2) full-term (37 weeks <= gestational age < 42 weeks) infants 3) Infants with informed consent by representative family 4) Infants considered healthy by the investigators

Exclusion criteria

Exclusion criteria: 1) Multiple-birth infants 2) Infants with small or large birth-weight for gestational age 3) Infants with any severe congenital disease in blood, liver, heart, kidney, gastro-intestine and so on or who are suspected with immune disorder 4) Infants whose mother has a serious disorder in liver, kidney, heart, blood, lung, endocrine system or metabolic system so on, or mental disorders 5) Infants who were administrated with probiotics or antibiotics 6) Infants who are planned to use probiotics other than the study supplement during the study 7) Infants considered to be unsuitable for enrollment by the investigators

Design outcomes

Primary

MeasureTime frame
Colonization of bifidobacteria

Secondary

MeasureTime frame
1. Intestinal environment 2. Biochemical measurements of stools 3. Defecation frequency and fecal condition 4. Health condition

Countries

Japan

Contacts

Public ContactRyuji Tsuno

Matsumoto City Hospital Pediatrics

hospi@city.matsumoto.lg.jp0263-92-3027

Outcome results

None listed

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