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

NCT06866990 | Not Yet Recruiting

• 1 other identifier: 2024-1343
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Premature Ovarian Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in antral follicle counts

  6 months

• Changes in perimenopausal symptom

  6 months

• Changes in mental and psychological status

  6 months

• Achievement of pregnancy

  8 months

• Changes in the gut microbiota.

  6 months

Study Arms (2)

Lactobacillus johnsonii

EXPERIMENTAL

Participants receive Lactobacillus johnsonii

Dietary Supplement: Lactobacillus johnsonii

Placebo

PLACEBO COMPARATOR

Participants receive placebo.

Other: Placebo

Interventions

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).

Lactobacillus johnsonii

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.

Placebo

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

CbsT2 protein, Lactobacillus johnsonii

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Liangjing Wang

CONTACT

86-13777848083; wangljzju@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 10, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share