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Effects of Continuous Ingestion of Bifidobacteria on Women's Health:A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study.

Effects of Continuous Ingestion of Bifidobacteria on Women's Health: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study. - Effects of Continuous Ingestion of Bifidobacteria on Women's Health

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055175
Enrollment
130
Registered
2024-08-06
Start date
2024-08-07
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 Adult

Interventions

Ingestion of test powder containing Bifidobacteria for a duration of 3 menstrual cycles. Intake of placebo powder for a duration of 3 menstrual cycles.

Sponsors

Macromill, Inc.
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1)Individuals aged between 25 and 34 years (2)ndividuals with a menstrual cycle of 25 to 38 days and a menstrual duration of 3 to 7 days

Exclusion criteria

Exclusion criteria: (1)Individuals who have or have a history of gynecological diseases (such as menorrhagia, secondary amenorrhea, breast cancer, endometriosis, uterine fibroids, endometrial cancer, cervical cancer, uterine body cancer, ovarian cancer, etc.) (2)Individuals who have suspected or have a history of mood disorders (such as clinical depression, premenstrual dysphoric disorder(PMDD), etc.) (3)Individuals who frequently use medications (including low-dose pills and herbal medicines)or quasi-drugs that are considered to have a significant impact on physical and mental symptoms related to menstruation (4)Individuals who cannot stop consuming specific health foods, functional foods, supplements, or foods (including specific Bifidobacteria or lactic acid bacteria)that are considered to affect physical and mental symptoms after registration (5)Heavy smokers (6)Heavy drinkers (60g or more of pure alcohol per day) (7)Individuals with disrupted lifestyles (8)Individuals who have or have a history of serious diseases, such as malignant tumors, respiratory diseases, liver, kidney, heart, lung, gastrointestinal, blood, endocrine, and metabolic disorders (9)Individuals who have or have a history of severe drug or food allergy (10)Individuals who are pregnant, intend to become pregnant during the trial period, or are breastfeeding (11)Individuals with a BMI of less than 18.5 kg/m 2 or 30 kg/m 2 or more (12)Individuals who are participating or plan to participate in other clinical trials for 4 weeks before the pre-examination to the end of the intake period (13)Individuals who are ineligible based on the principal investigator's judgment.

Design outcomes

Primary

MeasureTime frame
menstrual distress questionnaire(MDQ)

Countries

Japan

Contacts

Public ContactAyumi Sugioka

Macromill, Inc. Life Science Division Clinical Research Unit

sugioka@macromill.com03-6716-0700

Outcome results

None listed

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