Premature Ovarian Failure (POF)Early Phase 1NCT07308327
The Influence of Gut Microbiota on Ovarian Function: A Single-center, Randomized,Double Blind, Parallel-controlled, Exploratory Clinical Trial
A Early Phase 1 study testing Akk Gut Bacteria Supplement in people with Premature Ovarian Failure (POF), run by Songling Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ovarian Failure (POF)
- What is being tested?
- Akk Gut Bacteria Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- 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);
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Intestinal Probiotics Dietary Supplement
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.
Read the 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)
- Being tested
- Akk Gut Bacteria Supplement, Give a placebo
- Keywords
- premature ovarian failure, intestinal bacteria
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akk Gut Bacteria SupplementDietary supplement
Taking the Aakk intestinal bacteria supplement for three months
Give a placeboOther
The appearance and smell of the placebo are the same as those of the active bacterial agent.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Akk Gut Bacteria Supplement; Other: Give a placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
gonadal hormone concentrations
Measured: After taking the medicine for three months
Number of antral follicles
Measured: After taking the medicine for three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian Failure (POF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Songling Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Songling Zhang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308327
- Sponsor's protocol ID
- 2025-HS-055
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Probiotics Dietary Supplement
- ClinicalTrials.gov ID
- NCT07308327
- Acronym / sponsor ID
- 2025-HS-055
- Conditions
- Premature Ovarian Failure (POF)
- Keywords
- premature ovarian failure, intestinal bacteria
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Songling ZhangUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –health comparison |
| POI/POF group | Experimental | Dietary Supplement: Akk Gut Bacteria Supplement, Other: Give a placeboGroup A: Administered the Akk. muciniphila bacteria, Group B: Did not administer the Akk. muciniphila bacteria. A 3-month clinical trial was conducted. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 1. Ovarian dysfunction
- Women have normal ovarian function;
- No history of menstrual irregularity and infertility;
- Regular menstruation;
- Normal FSH levels (< 10 IU/L);
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Akk Gut Bacteria SupplementTaking the Aakk intestinal bacteria supplement for three months | Dietary supplement | POI/POF group |
| Give a placeboThe appearance and smell of the placebo are the same as those of the active bacterial agent. | Other | POI/POF group |
Primary outcome
gonadal hormone concentrations
Time frame: After taking the medicine for three months
Number of antral follicles
Time frame: After taking the medicine for three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Akk Gut Bacteria Supplement in people with Premature Ovarian Failure (POF), run by Songling Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gonadal hormone concentrations (time frame: After taking the medicine for three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.