Clinical trial NCT06866990: Exploratory Clinical Study on the Efficacy and Safety of Lactobacillus Johnsonii in the Treatment of Patients with Premature Ovarian Insufficiency
Official title: Exploratory Clinical Study on the Efficacy and Safety of Lactobacillus Johnsonii in the Treatment of Patients with Premature Ovarian Insufficiency
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Ovarian Insufficiency
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Ovarian function markers
timeFrame: 6 months
Secondary outcomes:
measure: Changes in antral follicle counts
timeFrame: 6 months
measure: Changes in perimenopausal symptom
timeFrame: 6 months
measure: Changes in mental and psychological status
timeFrame: 6 months
measure: Achievement of pregnancy
timeFrame: 8 months
measure: Changes in the gut microbiota.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: