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

A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study of the Efficacy of 1-Kestose on the Intestinal Environment of Pregnant Women.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031210087
Enrollment
70
Registered
2021-05-13
Start date
2021-05-13
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 pregnant woman

Interventions

Once a day, dissolve 1-Kestose or maltose (placebo) 3 grams in water (tap water, in principle. If this is difficult, dissolve in mineral water, hot water, coffee, tea, miso soup, etc.) and take it bef

Sponsors

Ide Yoshihiro
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Healthy pregnant women who are between 20 and 40 years of age at the time of consent. 2) Patients who have received sufficient explanation about the study, can understand the contents, and can give written consent in person.

Exclusion criteria

Exclusion criteria: 1) Patients on medication 2) Those with gestational diabetes or high blood pressure in pregnancy 3) Those who have taken drugs (antibiotics) that affect the intestinal environment for one month prior to the start of the test food intake 4) Those who have a history of or are currently suffering from a serious disease of the heart, liver, kidneys, digestive organs, etc. 5) Heavy drinkers of alcohol 6) Smokers 7) Those with extremely irregular dietary habits, working hours, or rhythm of life 8) Those who are allergic to kestose or maltose 9) 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 of completion of the trial, or after consenting to participate in the trial. 10) Those who are judged inappropriate to participate in the study by the principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Intestinal microbiota and intestinal metabolites.

Secondary

MeasureTime frame
Blood biochemical test, blood bile acids, blood short-chain fatty acids, saliva IgA, stool IgA, defecation status, atopy in children and eczema incidence in children.

Contacts

Public ContactYoshihiro Ide

Nihonkai General Hospital

ideyosi@nihonkai-hos.jp+81-234-26-2001

Outcome results

None listed

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