Efficacy of Inactivated Akkermansia muciniphila in Obese Patients with Polycystic Ovary Syndrome via Improving Insulin Resistance

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600124649

Enrollment

Unknown

Registered

2026-05-14

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-05-18

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

Conditions

Polycystic Ovary Syndrome

Interventions

Experimental group:Treatment with inactivated Akkermansia muciniphila combined with metformin

Control group:Placebo combined with metformin therapy

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 18-40 years. 2. The diagnostic criteria for polycystic ovary syndrome follow the Rotterdam criteria, meeting 2 of the following 3 items: infrequent or absent ovulation; clinical and/or biochemical hyperandrogenism; ultrasound showing polycystic ovarian changes (one or both ovaries with 2-9mm follicles >=12, and/or ovarian volume >=10 mL). 3.24 1.66-2.67, fasting insulin level >10-15 µU/mL, or oral glucose tolerance test (OGTT) shows impaired glucose tolerance; 5. No use of any medications affecting menstruation (such as contraceptives, hormones, or other drugs affecting insulin, blood sugar, sex hormones, and lipid metabolism) within the past 3 months, and no related treatments, and no history of induced abortion. 6. No use of antibiotics, prebiotics/probiotics, or hormone drugs (such as oral contraceptives, metformin, glucocorticoids) in the past 3 months. 7. Voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnancy, breastfeeding, or planning to become pregnant. 2. Having other serious endocrine diseases (such as Cushing's syndrome, congenital adrenal hyperplasia, uncontrolled thyroid dysfunction), type 1 or type 2 diabetes. 3. Acute gastrointestinal disease, inflammatory bowel disease, or history of gastrointestinal surgery in the past 3 months. 4. Severe dysfunction of the heart, liver, or kidneys, or immune system diseases. 5. Use of antibiotics, probiotics, or hormonal drugs (such as oral contraceptives, metformin, glucocorticoids) in the past 3 months. 6. Other situations deemed unsuitable for participation by the researcher.

Design outcomes

Primary

Measure	Time frame
HOMA-IR;	—

Secondary

Measure	Time frame
Menstrual cycle regularity;endocrine hormones;	—

Countries

China

Contacts

Public ContactSun Lihua

Shanghai East Hospital

lihua-sun@163.com+86 21 20334527

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026