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

March 5, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in antral follicle counts
Time Frame: 6 months
6 months
Changes in perimenopausal symptom
Time Frame: 6 months
MENQOL Score (Menopause-Specific Quality of Life Questionnaire)
6 months
Changes in mental and psychological status
Time Frame: 6 months
DASS-21 Scale (Depression, Anxiety, and Stress Scale-21)
6 months
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.
8 months
Changes in the gut microbiota.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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