Premature Ovarian InsufficiencyNCT06866990
Exploratory Clinical Study on the Efficacy and Safety of Lactobacillus Johnsonii in the Treatment of Patients with Premature Ovarian Insufficiency
A study testing Lactobacillus johnsonii in people with Premature Ovarian Insufficiency, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Premature Ovarian Insufficiency
- What is being tested?
- Lactobacillus johnsonii
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Lactobacillus johnsonii, Placebo
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus johnsoniiDietary 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).
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus johnsonii | Experimental | Participants receive Lactobacillus johnsonii Receives: Dietary Supplement: Lactobacillus johnsonii |
| Placebo | Placebo comparator | Participants receive placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Changes in antral follicle counts
Measured: 6 months
Changes in perimenopausal symptom
MENQOL Score (Menopause-Specific Quality of Life Questionnaire)
Measured: 6 months
Changes in mental and psychological status
DASS-21 Scale (Depression, Anxiety, and Stress Scale-21)
Measured: 6 months
Achievement of pregnancy
Pregnancy outcomes achieved through natural or assisted conception methods include biochemical pregnancy, clinical pregnancy, miscarriage, and ectopic pregnancy.
Measured: 8 months
Changes in the gut microbiota.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866990
- Sponsor's protocol ID
- 2024-1343
- Status last verified
- Jan 2025
- First submitted
- 5 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study on the Efficacy and Safety of Lactobacillus Johnsonii in the Treatment of Patients with Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT06866990
- Acronym / sponsor ID
- 2024-1343
- Conditions
- Premature Ovarian Insufficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus johnsonii | Experimental | Dietary Supplement: Lactobacillus johnsoniiParticipants receive Lactobacillus johnsonii |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive placebo. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus johnsoniiThe 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). | Dietary supplement | Lactobacillus johnsonii |
| PlaceboThe 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. | Other | Placebo |
Primary outcome
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.
5 secondary outcomes
Changes in antral follicle counts
Time frame: 6 months
Changes in perimenopausal symptom
Time frame: 6 months
Changes in mental and psychological status
Time frame: 6 months
Achievement of pregnancy
Time frame: 8 months
Changes in the gut microbiota.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus johnsonii in people with Premature Ovarian Insufficiency, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liangjing Wang (86-13777848083, wangljzju@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian function markers (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.