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

JRCT ID: jRCTs031230592

Registered date:25/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy pregnant women and offspring
• Date of first enrollment: 25/01/2024
• Target sample size: 220
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Bifidobacteria counts at 1 month of age in infants born to mothers treated with Kestose and non-treated mothers

Secondary Outcome

1) 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
• Gender: Both

Include criteria

pregnant 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 criteria

pregnant 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

• Primary Sponsor: Nakano Taiji
• Secondary Sponsor: Shimojo Naoki
• Source(s) of Monetary Support: Natural Science Co.,Ltd.,Chiba University Hospital