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A clinical randomized controlled trial on the improvement effect of postbiotics on ovarian insufficiency

A clinical randomized controlled trial on the improvement effect of postbiotics on ovarian insufficiency

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110866
Enrollment
Unknown
Registered
2025-10-22
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with ovarian insufficiency

Interventions

POI:None
Control:None
Placebo:placebo

Sponsors

Jingdezhen Second People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Women aged 18–40 years diagnosed with premature ovarian insufficiency (POI), with normal body weight and height. Diagnosis of POI must meet at least two of the following criteria: Baseline FSH level > 10 IU/L; Oligomenorrhea or amenorrhea for at least two consecutive cycles (interval > 4 weeks); Fluctuating decline in estrogen levels; Anti-Müllerian hormone (AMH) < 1.0–1.2 ng/mL; Basal antral follicle count (AFC) < 5–7 on ultrasound. 2.General condition good; no severe dysfunction of the heart, lungs, kidneys, or liver; no metabolic diseases. 3.No use of antibiotics, other medications, or probiotics within 3 months prior to enrollment after treatment completion.

Exclusion criteria

Exclusion criteria: 1.Patients who do not meet the above inclusion criteria; 2.Severe active viral or bacterial infections that are not adequately controlled; 3.Any severe or chronic conditions that, in the opinion of the investigator, may interfere with treatment, follow-up, or assessment. This includes but is not limited to: Uncontrolled clinically significant neurological or psychiatric disorders; Immunomodulatory diseases; Metabolic disorders; Infectious diseases. 4.Patients deemed by the clinician as unsuitable for probiotic adjunctive therapy after evaluation;

Design outcomes

Primary

MeasureTime frame
Sex hormone;

Secondary

MeasureTime frame
gut microbiota;

Countries

China

Contacts

Public ContactXiaohui Wang

Jingdezhen Second People’s Hospital

1007219161@qq.com+86 798 820 1590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026