Test of the effect of 1-Kestose on the intestinal environment of Pregnant Women.

JRCT ID: jRCTs031210088

Registered date:13/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Dermatitis and Eczema
• Date of first enrollment: 13/05/2021
• Target sample size: 70
• Study type: Interventional
• Intervention(s): Once a day, 1-Kestose or maltose (placebo) 1 grams should be dissolved in food such as baby food or water (water, hot water, tea, miso soup, etc.) and taken before meals. Take it every day, although the timing of ingesting is not limited to morning, lunch and dinner. Do not prepare the test food in a container such as a pot, but dissolve it in water each time.

Outcome(s)

• Primary Outcome: Intestinal microbiota and intestinal metabolites.
• Secondary Outcome: Saliva IgA content, stool IgA content, defecation status, POEM score and SCOR score

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: < 4age old
• Gender: Both

Include criteria

Infants diagnosed with atopic dermatitis who are between 1 and 4 years old at the time of consent acquisition.
2) The research participant whose parent or guardian has received sufficient explanation of the research, understands its contents, and can provide written consent.

Exclude criteria

Those who use topical steroids classified as strongyles (group I) or belly-strength (group II) as described in the "Atopic Dermatitis Clinical Practice Guidelines 2018
2) Those who have taken drugs (antibiotics) that affect the intestinal environment for one month prior to the start of the test food intake or will take them during the test.
3) Those who have a history of or are currently suffering from serious diseases of the heart, liver, kidneys, digestive organs, etc.
4) Those who are allergic to kestose or maltose.
5) Those who are currently participating in a clinical trial of another drug or health food, or who plan to participate in another clinical trial within 4 weeks after the completion of the trial, or after consenting to participate in the trial.
6) Those who are judged inappropriate to participate in the study by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: Ide Yoshihiro
• Source(s) of Monetary Support: Metabologenomics, Inc. (Fiscal year 2020 commercial and service competitiveness strengthening cooperation support project)