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RecruitingNCT06987279Updated May 23, 2025

Lactobacillus Plantarum and Hormonal Regulation in Obese Women

An interventional study of Probiotic and Maltodextrin in Obesity, Women, sponsored by Wecare Probiotics Co., Ltd.. Recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by Wecare Probiotics Co., Ltd. · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

To evaluate the regulatory effect of Lactobacillus plantans Lp90 formula on visceral fat metabolism and sex hormone balance in obese women.

02

Conditions studied

  • Obesity, Women
03

In context

Lead sponsor

Wecare Probiotics Co., Ltd. is the lead sponsor of 65 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age: 18 to 40 years old, female, BMI ≥ 25 kg/m2.
  2. Be willing to receive follow-up during the intervention period.
  3. Be willing to provide two blood, urine and fecal samples during the intervention period.
  4. Be willing to take the compound probiotics by oneself every day during the intervention period.
  5. Have good hearing and be able to hear and understand all instructions during the intervention period.

Exclusion criteria

-

Exclusion Criteria:

  1. Suffering from digestive system diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease).
  2. 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).
  3. Have received/are currently receiving treatment for the following mental illnesses: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder.
  4. Take medication for depression or low mood.
  5. Suffering from internal organ failure (such as heart, liver or kidney failure, etc.).
  6. Have received radiotherapy or chemotherapy in the past.
  7. 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.

  8. Have suffered from hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past.

    -

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Probiotic Group

    Take Lactobacillus plantarum Lp90 at 30 billion CFU per day.

    Dietary Supplement: Probiotic

  • Placebo comparator
    Placebo Group

    Taking maltodextrin 3 g/day.

    Dietary Supplement: Maltodextrin

Interventions

  • Dietary supplementProbiotic

    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).

  • Dietary supplementMaltodextrin

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0, 1, 2, 3 months

07

Study locations

1 of 1 sites recruiting
  • Fuwai Central-China Cardiovascular Hospital
    Zhengzhou, Henan 462000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06987279
Lead sponsor
Wecare Probiotics Co., Ltd.
Responsible party
Sponsor
First posted
May 23, 2025
Start date
Jun 10, 2025 (estimated)
Primary completion
Sep 10, 2025 (estimated)
Completion
Dec 10, 2025 (estimated)
Last update
May 23, 2025

Study contacts

Yingpeng Tian, Doctor
Contact
tianyingpeng2021@163.com
13671979116 ext. ＋86

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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