Exploratory Clinical Study on the Efficacy and Safety of Lactobacillus Johnsonii in the Treatment of Patients with Premature Ovarian Insufficiency

NCT ID: NCT06866990

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-08-31

Brief Summary

The goal of this clinical trial is to explore the effectiveness and safety of Lactobacillus johnsonii in improving ovarian function and perimenopausal symptoms in patients with premature ovarian insufficiency (POI). The main questions it aims to answer are: ① To explore the effectiveness and safety of Lactobacillus johnsonii in improving ovarian function and perimenopausal symptoms in patients with POI; ② To explore the potential mechanism of action of Lactobacillus johnsonii in improving ovarian function and perimenopausal symptoms in patients with POI. Participants who meet all the inclusion criteria will be enrolled in the study and randomly assigned in a 1:1 ratio to either the Lactobacillus johnsonii group or the placebo group.

Conditions

Premature Ovarian Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lactobacillus johnsonii

Participants receive Lactobacillus johnsonii

Group Type: EXPERIMENTAL

Lactobacillus johnsonii

Intervention Type: DIETARY_SUPPLEMENT

The investigational product is a probiotic containing Lactobacillus johnsonii. It is recommended to be stored under refrigerated conditions at approximately 4°C. Participants are instructed to take one sachet twice daily, dissolved in warm water, with a total daily oral dose exceeding 1×10¹¹ colony-forming units (CFU).

Placebo

Participants receive placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The placebo product contains the same excipients as the investigational product, except for the absence of Lactobacillus johnsonii. It is identical to the investigational product in appearance, color, weight, and taste. It is recommended to be stored under refrigerated conditions at approximately 4°C. The administration method is the same as that of the experimental group.

Interventions

Lactobacillus johnsonii

The investigational product is a probiotic containing Lactobacillus johnsonii. It is recommended to be stored under refrigerated conditions at approximately 4°C. Participants are instructed to take one sachet twice daily, dissolved in warm water, with a total daily oral dose exceeding 1×10¹¹ colony-forming units (CFU).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The placebo product contains the same excipients as the investigational product, except for the absence of Lactobacillus johnsonii. It is identical to the investigational product in appearance, color, weight, and taste. It is recommended to be stored under refrigerated conditions at approximately 4°C. The administration method is the same as that of the experimental group.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age between 20 and 39 years;

2. Irregular menstruation or amenorrhea for > 4 months;

3. At least two serum baseline follicle-stimulating hormone (FSH) levels > 25 IU/L (with an interval of more than 4 weeks between measurements);

4. Willing to voluntarily participate in this study, sign the informed consent form, and comply with the investigation and follow-up;

5. Not having participated in other clinical trials within the past 3 months.

Exclusion Criteria

1. Use of antibiotics or probiotics, prebiotics, and live bacterial preparations within the past month or during the intervention period;

2. Received hormone replacement therapy within the past 2 months;

3. Chromosomal abnormalities and genetic defects;

4. Iatrogenic premature ovarian insufficiency;

5. Stage IV endometriosis;

6. Uncontrolled endocrine diseases or autoimmune diseases;

7. Organic gastrointestinal diseases;

8. Infectious diseases of the reproductive, urinary, or digestive systems;

9. Severe cardiovascular, respiratory, renal, hematologic, endocrine, neurological, psychiatric, or other systemic diseases that the investigator believes may interfere with the study evaluation;

10. History of venous thromboembolism;

11. Allergic or intolerant to the components of the investigational probiotic product;

12. Allergic to two or more types of food/medications;

13. Refusal to provide written informed consent;

14. Other conditions deemed unsuitable for participation in the study by the investigator.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Liangjing Wang

Role: CONTACT

wangljzju@zju.edu.cn

86-13777848083

Other Identifiers

2024-1343

Identifier Type: -

Identifier Source: org_study_id