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NCT Number: NCT06866990

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

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.

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Key information

Conditions

Premature Ovarian Insufficiency Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Primary Ovarian Insufficiency Urogenital Diseases

Age range

20 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus johnsonii

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

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.

Primary outcomes

  1. 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

  1. Changes in antral follicle counts

    Time frame: 6 months

  2. Changes in perimenopausal symptom

    Time frame: 6 months

    MENQOL Score (Menopause-Specific Quality of Life Questionnaire)

  3. Changes in mental and psychological status

    Time frame: 6 months

    DASS-21 Scale (Depression, Anxiety, and Stress Scale-21)

  4. Achievement of pregnancy

    Time frame: 8 months

    Pregnancy outcomes achieved through natural or assisted conception methods include biochemical pregnancy, clinical pregnancy, miscarriage, and ectopic pregnancy.

  5. Changes in the gut microbiota.

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Liangjing Wang

CONTACT

[email protected]

86-13777848083

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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