JPRN-jRCTs031210087
Active, not recruiting
Phase 2
A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study of the Efficacy of 1-Kestose on the Intestinal Environment of Pregnant Women.
Ide Yoshihiro0 sites70 target enrollmentMay 13, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ide Yoshihiro
- Enrollment
- 70
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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