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

NCT07308327 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: 2025-HS-055
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Ovarian Failure (POF)

Keywords

premature ovarian failure; intestinal bacteria

Outcome Measures

Primary Outcomes (2)

• gonadal hormone concentrations

  After taking the medicine for three months

• Number of antral follicles

  After taking the medicine for three months

Study Arms (2)

control group

NO INTERVENTION

health comparison

POI/POF group

EXPERIMENTAL

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

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

Interventions

Akk Gut Bacteria Supplement DIETARY_SUPPLEMENT

Taking the Aakk intestinal bacteria supplement for three months

POI/POF group

Give a placebo OTHER

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

POI/POF group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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:
• Women have normal ovarian function;
• No history of menstrual irregularity and infertility;
• Regular menstruation;
• Normal FSH levels (\< 10 IU/L);
• 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);

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Songling Zhang: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Model Details: A randomized, double-blind, parallel-controlled, exploratory clinical trial was conducted on patients with ovarian dysfunction. The participants were randomly divided into two groups: Group A: received Akk. muciniphila bacteria, Group B: did not receive Akk. muciniphila bacteria. The clinical trial lasted for 3 months. Patients in Group A took one supplement of Akk. muciniphila bacteria daily. An early telephone visit was planned 15 days after supplementing with Akk. muciniphila bacteria (checking for abdominal distension, diarrhea, abdominal pain, nausea, vomiting, and changes in weight, etc.). Patients in Group B did not take Akk. muciniphila bacteria and were given a placebo (such as maltodextrin). The appearance and smell of the placebo were the same as the active bacterial supplement to avoid the introduction of bias through open-label. After 3 months, the samples were collected again at the hospital.

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: March 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)