Obesity, WomenNCT07013409
Probiotics' Effects on Hormones, Body and Mood in Obese Women
A study testing Probiotic and Maltodextrin in people with Obesity, Women, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
To evaluate the regulatory effect of probiotics formula on visceral fat metabolism and sex hormone balance in obese women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Women
- What is being tested?
- Probiotic and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2025to 4 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 40 years old, female, BMI ≥ 25 kg/m2.
- Be willing to receive follow-up during the intervention period.
- Be willing to provide two blood, urine and fecal samples during the intervention period.
- Be willing to take the compound probiotics by oneself every day during the intervention period.
- Have good hearing and be able to hear and understand all instructions during the intervention period.
Who cannot join
- Suffering from digestive system diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease).
- Suffering from severe neurological disorders (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, long-term coma - excluding general anesthesia).
- Have received/are currently receiving treatment for the following mental illnesses: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder.
- Take medication for depression or low mood.
- Suffering from internal organ failure (such as heart, liver or kidney failure, etc.).
- Have received radiotherapy or chemotherapy in the past.
- Have received general anesthesia surgery/procedures within the past three years, or plan to receive general anesthesia procedures/surgeries within the next three months during this trial.
- Have suffered from hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 462000
About this study
Official title: Safety and Efficacy of Lacticaseibacillus Rhamnosus LRa05, Lactobacillus Crispatus LCr86 and Limosilactobacillus Reuteri LR08 on Hormone Metabolism, Body Composition, and Emotional Regulation in Overweight Women
To evaluate the regulatory effect of probiotics formula on visceral fat metabolism and sex hormone balance in obese women.
- Conditions
- Obesity, Women
- Being tested
- Probiotic, Maltodextrin
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The trial period of this study is 3 months, and each patient will undergo 4 visits (in month 0, month 1, month 2, and month 3).
MaltodextrinDietary supplement
The trial period of this study is 3 months, and each patient will undergo 4 visits (in month 0, month 1, month 2, and month 3).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Experimental | Take 30 billion CFU of complex probiotics every day Receives: Dietary Supplement: Probiotic |
| Placebo Group | Placebo comparator | Taking maltodextrin 3 g/day. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of estradiol before and after the intervention
The serum estrogen content of the subjects before and after the intervention was detected by enzyme-linked immunosorbent assay.
Measured: 0, 1, 2, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start8 Jul 2025
- Primary completion30 Sep 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, WomenStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013409
- Sponsor's protocol ID
- WK20250603
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yin L, Wang S, Liu Y, Zhu C, Wang Z, Wang S, Cai Y, Xu F, Cheng Q. Safety and Efficacy of Lacticaseibacillus rhamnosus LRa05, Limosilactobacillus reuteri LR08 and Lactobacillus crispatus LCr86 on Hormone Metabolism, Body Composition, and Emotional Regulation in Overweight Women: A Randomized, Double - Blind, Placebo - Controlled Trial. J Appl Microbiol. 2026 Sep 12:lxag230. doi: 10.1093/jambio/lxag230. Online ahead of print.
PubMed 42731127
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Lacticaseibacillus Rhamnosus LRa05, Lactobacillus Crispatus LCr86 and Limosilactobacillus Reuteri LR08 on Hormone Metabolism, Body Composition, and Emotional Regulation in Overweight Women
- ClinicalTrials.gov ID
- NCT07013409
- Acronym / sponsor ID
- WK20250603
- Conditions
- Obesity, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 10 Jun 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.
To evaluate the regulatory effect of probiotics formula on visceral fat metabolism and sex hormone balance in obese women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Dietary Supplement: ProbioticTake 30 billion CFU of complex probiotics every day |
| Placebo Group | Placebo comparator | Dietary Supplement: MaltodextrinTaking maltodextrin 3 g/day. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18 to 40 years old, female, BMI ≥ 25 kg/m2.
- Be willing to receive follow-up during the intervention period.
- Be willing to provide two blood, urine and fecal samples during the intervention period.
- Be willing to take the compound probiotics by oneself every day during the intervention period.
- Have good hearing and be able to hear and understand all instructions during the intervention period.
Key exclusion criteria (8 listed)
- Suffering from digestive system diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease).
- Suffering from severe neurological disorders (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, long-term coma - excluding general anesthesia).
- Have received/are currently receiving treatment for the following mental illnesses: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder.
- Take medication for depression or low mood.
- Suffering from internal organ failure (such as heart, liver or kidney failure, etc.).
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 |
|---|---|---|
| ProbioticThe trial period of this study is 3 months, and each patient will undergo 4 visits (in month 0, month 1, month 2, and month 3). | Dietary supplement | Probiotic Group |
| MaltodextrinThe trial period of this study is 3 months, and each patient will undergo 4 visits (in month 0, month 1, month 2, and month 3). | Dietary supplement | Placebo Group |
Primary outcome
The changes of estradiol before and after the intervention
Time frame: 0, 1, 2, 3 months
The serum estrogen content of the subjects before and after the intervention was detected by enzyme-linked immunosorbent assay.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Derived from this study: PubMed 42731127Yin L, Wang S, Liu Y, Zhu C, Wang Z, Wang S, Cai Y, Xu F, Cheng Q. Safety and Efficacy of Lacticaseibacillus rhamnosus LRa05, Limosilactobacillus reuteri LR08 and Lactobacillus crispatus LCr86 on Hormone Metabolism, Body Composition, and Emotional Regulation in Overweight Women: A Randomized, Double - Blind, Placebo - Controlled Trial. J Appl Microbiol. 2026 Sep 12:lxag230. doi: 10.1093/jambio/lxag230. Online ahead of print.
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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 study testing Probiotic and Maltodextrin in people with Obesity, Women, run by Wecare Probiotics Co., Ltd. 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 6 Jul 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The changes of estradiol before and after the intervention (time frame: 0, 1, 2, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07013409, which also lists 1 linked publication.
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 6 Jul 2026.