ObesityNCT07502404
Lactobacillus Gasseri and Hormonal Regulation in Obese Women
A study testing Probiotic and Maltodextrin in people with Obesity and Women, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
To evaluate the regulatory effect of Lactobacillus gasseri LG08 formula on visceral fat metabolism and sex hormone balance in obese women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- What is being tested?
- Probiotic and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2025to 25 Oct 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female sex, aged 18-50 years; (2) body mass index (BMI) ≥ 25 kg/m2; (3) willingness to maintain habitual dietary intake and physical activity patterns throughout the study period and to comply with follow-up visits, sample collection, and questionnaire completion; (4) ability to complete blood sampling during the early follicular phase of the menstrual cycle (days 3-5), as confirmed by self-reported menstrual timing.
- -
Who cannot join
- pregnancy or lactation; (2) presence of chronic diseases or endocrine/metabolic disorders (e.g., diabetes mellitus, thyroid disorders); (3) recent use of medications or dietary supplements that could affect endocrine or metabolic function; (4) non-compliance with the required washout period or prohibited use of probiotic products during the study; (5) any other conditions deemed by the investigators to be unsuitable for participation.
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Central-China Cardiovascular Hospital
Zhengzhou, Henan, 462000
About this study
Official title: Impact of Lactobacillus Gasseri on Weight Management and Endocrine Function in Overweight Women: A Randomized Clinical Trial
To evaluate the regulatory effect of Lactobacillus gasseri LG08 formula on visceral fat metabolism and sex hormone balance in obese 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 12 weeks, and each patient will undergo 4 visits (in week 0, week 4, week 8, and week 12).
MaltodextrinDietary supplement
The trial period of this study is 12 weeks, and each patient will undergo 4 visits (in week 0, week 4, week 8, and week 12).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Experimental | Take Lactobacillus gasseri LG08 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: Week 0 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start28 Apr 2025
- Primary completion21 Jul 2025
- Study completion25 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 110 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
- NCT07502404
- Sponsor's protocol ID
- WK20260325
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 31 Mar 2026
- 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 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lactobacillus Gasseri on Weight Management and Endocrine Function in Overweight Women: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07502404
- Acronym / sponsor ID
- WK20260325
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 25 Oct 2025 (actual)
- First posted
- 31 Mar 2026 (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 gasseri LG08 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 gasseri LG08 per day. |
| Placebo Group | Placebo comparator | Dietary Supplement: MaltodextrinTaking maltodextrin 3 g/day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- female sex, aged 18-50 years; (2) body mass index (BMI) ≥ 25 kg/m2; (3) willingness to maintain habitual dietary intake and physical activity patterns throughout the study period and to comply with follow-up visits, sample collection, and questionnaire completion; (4) ability to complete blood sampling during the early follicular phase of the menstrual cycle (days 3-5), as confirmed by self-reported menstrual timing.
- -
Key exclusion criteria (2 listed)
- pregnancy or lactation; (2) presence of chronic diseases or endocrine/metabolic disorders (e.g., diabetes mellitus, thyroid disorders); (3) recent use of medications or dietary supplements that could affect endocrine or metabolic function; (4) non-compliance with the required washout period or prohibited use of probiotic products during the study; (5) any other conditions deemed by the investigators to be unsuitable for participation.
- -
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 12 weeks, and each patient will undergo 4 visits (in week 0, week 4, week 8, and week 12). | Dietary supplement | Probiotic Group |
| MaltodextrinThe trial period of this study is 12 weeks, and each patient will undergo 4 visits (in week 0, week 4, week 8, and week 12). | Dietary supplement | Placebo Group |
Primary outcome
The changes of estradiol before and after the intervention
Time frame: Week 0 and Week 12
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 31 Mar 2026.
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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 and 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 2 inclusion and 2 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 31 Mar 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: Week 0 and Week 12). 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 31 Mar 2026.