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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Akk Gut Bacteria Supplement | Dietary Supplement | Taking the Aakk intestinal bacteria supplement for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| gonadal hormone concentrations | After taking the medicine for three months | |
| Number of antral follicles | After taking the medicine for three months |
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Inclusion Criteria:
1. Ovarian dysfunction
Control group:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | China |
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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.
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| Give a placebo | Other | The appearance and smell of the placebo are the same as those of the active bacterial agent. |
|
| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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