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

NCT ID: NCT07308327

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed 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.

Conditions

Premature Ovarian Failure (POF)

Keywords

premature ovarian failure; intestinal bacteria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control group

health comparison

Group Type: NO_INTERVENTION

No interventions assigned to this group

POI/POF group

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

Group Type: EXPERIMENTAL

Akk Gut Bacteria Supplement

Intervention Type: DIETARY_SUPPLEMENT

Taking the Aakk intestinal bacteria supplement for three months

Give a placebo

Intervention Type: OTHER

The appearance and smell of the placebo are the same as those of the active bacterial agent.

Interventions

Akk Gut Bacteria Supplement

Taking the Aakk intestinal bacteria supplement for three months

Intervention Type: DIETARY_SUPPLEMENT

Give a placebo

The appearance and smell of the placebo are the same as those of the active bacterial agent.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Songling Zhang

OTHER

Sponsor Role: lead

Responsible Party

Songling Zhang

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

2025-HS-055

Identifier Type: -

Identifier Source: org_study_id