Exploratory Clinical Study on the Efficacy and Safety of Lactobacillus Johnsonii in the Treatment of Patients with Premature Ovarian Insufficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lactobacillus johnsonii, Placebo.
- Who it may be relevant to
- Registry conditions: Premature Ovarian Insufficiency. Basic parameters: 20 years — 39 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement 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). - Other 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.
Primary outcome measures
- Ovarian function markers [Time frame: 6 months]
Secondary outcome measures (5)
- Changes in antral follicle counts [Time frame: 6 months]
- Changes in perimenopausal symptom [Time frame: 6 months]
- Changes in mental and psychological status [Time frame: 6 months]
- Achievement of pregnancy [Time frame: 8 months]
- Changes in the gut microbiota. [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06866990 · 2024-1343