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The effect of Lactobacillus johnsonii on improving ovarian function in perimenopausal women (aged 40-50): a single arm study

The effect of Lactobacillus johnsonii on improving ovarian function in perimenopausal women (aged 40-50): a single arm study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072828
Enrollment
Unknown
Registered
2023-06-26
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian function

Interventions

Sponsors

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1) Between the ages of 40 and 50, perimenopausal; 2) Women with menopause or menstrual disorders for 2 months (or more) and FSH>25U/L; 3) Those who have used medication have completed the washout period requirements; 4) Voluntarily participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Artificial menopause (bilateral ovariectomy/hysterectomy/radiation chemotherapy destroying ovarian function, etc.), gynecological organic lesions (maximum diameter of uterine fibroids>2cm), patients with severe breast hyperplasia, menopausal individuals with vaginal color ultrasound monitoring of endometrium (double layer) = 0.5cm, endometriosis, adenomyosis, ovarian cysts (maximum diameter = 3cm or simple ovarian cysts), endometrial polyps, abnormal uterine bleeding Malignant tumor patients; 2) Complicated with cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, diabetes and other serious primary diseases; 3) Previously diagnosed with hyperthyroidism, hypothyroidism, or hyperlipidemia, and still requiring medication treatment; 4) Allergic constitution (people who are allergic to two or more foods/drugs); 5) Patients with trichomonas, fungal or bacterial vaginal infections, urinary tract infections, and other diseases; 6) Patients who have used traditional Chinese medicine/Western medicine with similar effects to the research product and have not reached the corresponding washout period specified in the protocol; 7) Individuals who are currently or have participated in other clinical studies within the past 3 months; 8) Vulnerable groups, including critically ill patients, mentally ill individuals, cognitive impairment individuals, minors, pregnant women, illiterate individuals, etc; 9) Researchers believe that there are other situations where it is not suitable to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
LH;FSH;E2;AMH;

Secondary

MeasureTime frame
Improved Kupperman Scale Scoring;Ovarian ultrasound examination;Structure of fecal microbiota;

Countries

China

Contacts

Public ContactChen Shujie

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University

4094108@qq.com+86 138 6748 9890

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026