Exploratory Clinical Study on the Efficacy and Safety of Lactobacillus Johnsonii in the Treatment of Patients with Premature Ovarian Insufficiency
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Primary Endpoint
- Ovarian function markers
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 20 and 39 years;
- •Irregular menstruation or amenorrhea for > 4 months;
- •At least two serum baseline follicle-stimulating hormone (FSH) levels > 25 IU/L (with an interval of more than 4 weeks between measurements);
- •Willing to voluntarily participate in this study, sign the informed consent form, and comply with the investigation and follow-up;
- •Not having participated in other clinical trials within the past 3 months.
Exclusion Criteria
- •Use of antibiotics or probiotics, prebiotics, and live bacterial preparations within the past month or during the intervention period;
- •Received hormone replacement therapy within the past 2 months;
- •Chromosomal abnormalities and genetic defects;
- •Iatrogenic premature ovarian insufficiency;
- •Stage IV endometriosis;
- •Uncontrolled endocrine diseases or autoimmune diseases;
- •Organic gastrointestinal diseases;
- •Infectious diseases of the reproductive, urinary, or digestive systems;
- •Severe cardiovascular, respiratory, renal, hematologic, endocrine, neurological, psychiatric, or other systemic diseases that the investigator believes may interfere with the study evaluation;
- •History of venous thromboembolism;
- •Allergic or intolerant to the components of the investigational probiotic product;
- •Allergic to two or more types of food/medications;
- •Refusal to provide written informed consent;
- •Other conditions deemed unsuitable for participation in the study by the investigator.
Arms & Interventions
Lactobacillus johnsonii
Participants receive Lactobacillus johnsonii
Intervention: Lactobacillus johnsonii (Dietary Supplement)
Placebo
Participants receive placebo.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Ovarian function markers
Time Frame: 6 months
Changes in sex hormone levels (including follicle-stimulating hormone, luteinizing hormone, estradiol, progesterone, testosterone, prolactin and anti-Müllerian hormone) and menstruation resumption.
Secondary Outcomes
- Changes in antral follicle counts(6 months)
- Changes in the gut microbiota.(6 months)
- Changes in perimenopausal symptom(6 months)
- Changes in mental and psychological status(6 months)
- Achievement of pregnancy(8 months)