Obesity, WomenNCT06987279
Lactobacillus Plantarum and Hormonal Regulation 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 Lactobacillus plantans Lp90 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
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2025to 10 Dec 2025
- Phase
- Interventional
- 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 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.
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- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Central-China Cardiovascular Hospital
Zhengzhou, Henan, 462000
Yingpeng Tian, 13671979116, tianyingpeng2021@163.com
About this study
Official title: Lactobacillus Plantarum Lp90 and Hormonal Regulation in Obese Women：A Randomized, Double-Blind, Placebo-Controlled Trial
To evaluate the regulatory effect of Lactobacillus plantans Lp90 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 Lactobacillus plantarum Lp90 at 30 billion CFU per 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 posted23 May 2025
- Study start10 Jun 2025 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 100 participants (estimated)
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
- NCT06987279
- Sponsor's protocol ID
- WK20250515
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Plantarum Lp90 and Hormonal Regulation in Obese Women：A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06987279
- Acronym / sponsor ID
- WK20250515
- Conditions
- Obesity, Women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2025 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 23 May 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 Lactobacillus plantans Lp90 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 Lactobacillus plantarum Lp90 at 30 billion CFU per 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 (6 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 (9 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
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 23 May 2025.
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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.
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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 23 May 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. 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?
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?
Contact Yingpeng Tian, Doctor (13671979116 ext. ＋86, tianyingpeng2021@163.com), or a site near the patient. 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?
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 23 May 2025.