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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-39
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Lactobacillus johnsonii
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations