The Influence of Gut Microbiota on Ovarian Function: A Single-center, Randomized,Double Blind, Parallel-controlled, Exploratory Clinical Trial

Songling Zhang

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Premature Ovarian Failure (POF)

Treatments: Dietary Supplement: Akk Gut Bacteria Supplement; Other: Give a placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07308327

2025-HS-055

Details and patient eligibility

About

In order to study the community profile of the intestinal microbiome in women with ovarian dysfunction, as well as the relationship between the changes in the intestinal microbiota and sex hormones, this study recruited 30 women with ovarian dysfunction and 30 healthy women. Sequencing was performed on the V3-V4 region of the 16S rDNA gene in fecal samples, and blood serum of the patients was collected for the study of changes in the systemic metabolome to reveal the significant differences in the intestinal microbiota between the subjects with ovarian dysfunction and the control group, as well as the related metabolic pathways.

Full description

At the same time, in order to evaluate the effectiveness, safety and tolerance of supplementing the Akk. muciniphila bacteria, as well as to explore the impact of supplementing Akk. muciniphila bacteria on human ovarian function, this study aims to be the first clinical research to explore the effect of supplementing Akk. muciniphila bacteria on human ovarian function.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. Ovarian dysfunction

  • Age < 40 years old; ② Irregular menstruation or amenorrhea for ≥ 4 months; ③ Two abnormal FSH levels (POF: FSH > 40 U/L; POI: FSH > 25 U/L); 2. Agree to participate in the study and be able to provide biological samples as required; 3. Body mass index within the normal range (18.5 kg/m² ≤ BMI < 24 kg/m²); 4. Strict contraception during treatment;

Control group:

1. Women have normal ovarian function;
2. No history of menstrual irregularity and infertility;
3. Regular menstruation;
4. Normal FSH levels (< 10 IU/L);
5. Age (< 40 years old) and body mass index (within the normal range 18.5 kg/m² ≤ BMI < 24 kg/m²) are matched with the case group; (The matching settings for the case group and the control group have been completed);

Exclusion criteria

• 1. Difficult to cooperate with researchers; 2. Those with congenital reproductive system disorders; 3. Those with chromosomal disorders; 4. Those with other systemic diseases; 5. Those with a history of ovarian surgery resection; 6. Chemotherapy/radiotherapy treatment; 7. Patients who have used antibiotics, antifungal drugs, antiviral drugs, proton pump inhibitors, corticosteroids or oral contraceptives within 3 months; 8. Patients who have been taking large doses of probiotic preparations for a long time.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

control group

No Intervention group

Description:

health comparison

POI/POF group

Experimental group

Description:

Group A: Administered the Akk. muciniphila bacteria, Group B: Did not administer the Akk. muciniphila bacteria. A 3-month clinical trial was conducted.

Treatment:

Other: Give a placebo

Dietary Supplement: Akk Gut Bacteria Supplement