Skip to content

A randomised controlled trial of kestose in growth promotion effect of bifodobacteria and safety in premature neonates

A randomised controlled trial of kestose in growth promotion effect of bifodobacteria and safety in premature neonates - Kestose administration trial in neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034023
Enrollment
60
Registered
2018-10-01
Start date
2018-10-01
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

Growth promotion effect of bifidobacteria

Interventions

Both groups are administered from hospitalization until discharge. &lt
Intervention&gt
1 packege of Bifidobacterium breve and 0.3 g of crystalline kestose powder and 1.125 ml of water for injection, and then administer 1 ml thereof once a day (the number of bacteria is 500 million). Bot
Control&gt
1 packege of Bifidobacterium breve and lactulose (Refolos syrup) 0.3 ml and 1 ml water for injection are mixed, 1 ml of which is administered once a day (the number of bacteria is 500 million).

Sponsors

Chiba University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Less than 2,000g of low birth weight infants who were admitted to NICU and GCU.

Exclusion criteria

Exclusion criteria: 1) Neonate whose birth weight 2000g or more. 2) Infants with surgical diseases (esophageal atresia, diaphragmatic hernia, etc.), with low possibility of long-term enteral nutrition 3) Neonates judged to be ineligible by research facility director or research doctor.

Design outcomes

Primary

MeasureTime frame
Amount of bifidobacteria in stool specimens collected at 1, 2, 4 weeks after birth in each group

Secondary

MeasureTime frame
1.16S gut microbiome analysis at 1, 2, 4 weeks after birth in each group 2.Measurement of short-chain fatty acids in stool specimens collected at 1, 2, 4 weeks after birth in each group 3.Frequency of defecation (days 0, 7, 14, 21, 28) 4.Difference in time until birth weight restoration in each group. 5.Weight gain rate upto corrected 40th week of gestational age in each group

Countries

Japan

Contacts

Public ContactSaori Tanaka

Chiba University Hospital Department of Pediatrics

happy_clover0708sao@yahoo.co.jp043-222-7171

Outcome results

None listed

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