Premature Ovarian Failure (POF)
Conditions
Keywords
premature ovarian failure, intestinal bacteria
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.
Interventions
DIETARY_SUPPLEMENTAkk Gut Bacteria Supplement
Taking the Aakk intestinal bacteria supplement for three months
OTHERGive a placebo
The appearance and smell of the placebo are the same as those of the active bacterial agent.
Sponsors
Songling Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gonadal hormone concentrations | After taking the medicine for three months |
| Number of antral follicles | After taking the medicine for three months |
Countries
China
Outcome results
None listed