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A study to test the efficacy of "mulberry leaf green juice" or "baby oligo (kestose)" in improving intestinal environment in pregnant females

Open study on safety and efficacy of "mulberry leaf green juice" or "baby oligo (kestose)" in pregnant females - Open study on safety and efficacy of prebiotics in pregnant females

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043026
Enrollment
50
Registered
2021-01-16
Start date
2020-09-23
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

Pregnant females

Interventions

Ingested food : &quot
mulberry leaf green juice&quot
Dose : Two packets per day Drink Period : 12 weeks Ingested food : &quot
baby oligo (kestose)&quot
Dose : Two packets per day Drink Period : 12 weeks

Sponsors

Natural Science Co.,Ltd. Research and Development Department
Lead Sponsor
Kanagawa Midwives Association B Food Science Co., Ltd. Healthcare Systems Co., Ltd.
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1)Patients who have received adequate explanation of the purpose and content of this study, are able to give informed consent, voluntarily volunteer after fully understood, and agree to participate in writing. 2)Japanese people aged 20 to <45 years at the time of informed consent 3)Those who between 12 and 25 weeks' gestation at baseline

Exclusion criteria

Exclusion criteria: 1)Patients with chronic disease who are receiving drug treatment or who have a history of disease 2)Individuals with allergies, etc. to the test article 3)Those currently taking foods or green juice containing mulberry leaf regularly 4)Those currently taking prebiotic or probiotic formulation or foods regularly 5)Those currently taking drugs, specified insurance foods, or health foods that may affect bowel movements 6)Those currently participating in another clinical trial or have participated in another clinical trial within 3 months prior to the start of the present study. 7)Women judged by the attending physicians and principal investigator as being inappropriate candidates for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Enteric environment (bifidobacterium, Bacteroides, Prevotella, Clostridium, total bacterial count et al.)—

Secondary

MeasureTime frame
Urinary indoxyl sulfate Urinary creatinine Urinary 8-OHdG Salivary IgA Questionnaire survey Safety assessment—

Countries

Japan

Contacts

Public ContactNozomi Ando

Natural Science Co.,Ltd. Research and Development Department

ando@natural-s.jp0356652311

Outcome results

None listed

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