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.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Ovarian Insufficiency
• Intervention / Treatment: Dietary supplement: Lactobacillus johnsonii; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liangjing Wang; Phone Number: 86-13777848083; Email: wangljzju@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants receive placebo.	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.
Experimental: Lactobacillus johnsonii; Participants receive Lactobacillus johnsonii	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ovarian function markers	Changes in sex hormone levels (including follicle-stimulating hormone, luteinizing hormone, estradiol, progesterone, testosterone, prolactin and anti-Müllerian hormone) and menstruation resumption.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in antral follicle counts		6 months
Changes in perimenopausal symptom	MENQOL Score (Menopause-Specific Quality of Life Questionnaire)	6 months
Changes in mental and psychological status	DASS-21 Scale (Depression, Anxiety, and Stress Scale-21)	6 months
Achievement of pregnancy	Pregnancy outcomes achieved through natural or assisted conception methods include biochemical pregnancy, clinical pregnancy, miscarriage, and ectopic pregnancy.	8 months
Changes in the gut microbiota.		6 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Premature Birth; Menopause, Premature; Primary Ovarian Insufficiency
• Other Study ID Numbers: 2024-1343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No