NIPH Clinical Trials Search

JRCT ID: jRCTs031230592

Registered date:25/01/2024

Study on the effect of kestose intake by mother on the gut microbiome of mother and child

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHealthy pregnant women and offspring
Date of first enrollment25/01/2024
Target sample size220
Countries of recruitment
Study typeInterventional
Intervention(s)Maternal consumption of 4 g/dose of kestose or maltose twice daily (8 g/day) from 28 weeks of pregnancy until 1 month postpartum.


Primary OutcomeBifidobacteria counts at 1 month of age in infants born to mothers treated with Kestose and non-treated mothers
Secondary Outcome1) Bifidobacteria count of pregnant women 2) Defecation status (frequency of defecation, fec al characteristics) of pregnant women 3) Total epithelial water loss (TEWL) in infants 4) Specific IgE/TARC level in 6 month old infants 5) Genetic polymorphisms related to skin barrier function (FLG, PNPLA1, SPINK5, and FUT2) in infants

Key inclusion & exclusion criteria

Age minimum>=
Age maximum< 45age old
Include criteriapregnant woman 1) Pregnant women who are scheduled to continue their prenatal checkups and have their delivery and postpartum checkups at the facility where the study is conducted 2) Pregnant women who are between 20 and 45 years of age at the time of consent 3) Pregnant women who are less than 26 weeks pregnant at the time of consent 4) Pregnant women who have received a full explanation of their participation in this study and who have given written consent of their own free will based on full understanding newborn 1) A newborn whose surrogate has been fully informed of the study, fully understands the study, and has given his/her free and voluntary written consent to participate in the study
Exclude criteriapregnant woman 1) Pregnant women with fetal morphological abnormalities, pregnant women with twins or more 2) pregnant women with a history of serious illness 3) Pregnant women who used antibiotics between 20 and 26 weeks of gestation 4) Pregnant women who will be treated with antibiotics at childbirth 5) Pregnant women who are allergic to the test food 6) Pregnant women who will intake of other oligosaccharides or prebiotics during this study period 7) Pregnant women who will participate other study (e.g. other foods, drugs or skin care products) during this study period 8) Pregnant women who cannot understand Japanese 9) Pregnant women who are judged to be ineligible by the principal investigator or subinvestigator newborn 1) Newborns with serious diseases

Related Information


Public contact
Name Naoki Shimojo
Address 1-8-1, Inohana, Chuo-ku chiba-shi, Chiba Chiba Japan 260-8670
Telephone +81-43-311-3613
Affiliation Chiba University
Scientific contact
Name Taiji Nakano
Address 1-8-1, Inohana, Chuo-ku chiba-shi, Chiba Chiba Japan 260-8670
Telephone +81-43-222-7171
Affiliation Chiba University Hospital