Recruiting NCT06987279
Lactobacillus Plantarum and Hormonal Regulation in Obese Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic, Maltodextrin.
- Who it may be relevant to
- Registry conditions: Obesity, Women. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Lactobacillus Plantarum Lp90 and Hormonal Regulation in Obese Women:A Randomized, Double-Blind, Placebo-Controlled Trial
Overview
To evaluate the regulatory effect of Lactobacillus plantans Lp90 formula on visceral fat metabolism and sex hormone balance in obese women.
Interventions
- Dietary supplement Probiotic
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 supplement Maltodextrin
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).
Primary outcome measures
- The changes of estradiol before and after the intervention [Time frame: 0, 1, 2, 3 months]
Eligibility criteria
Inclusion criteria
- 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.
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Exclusion criteria
- 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.
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Fuwai Central-China Cardiovascular Hospital — Zhengzhou
Identifiers
NCT: NCT06987279 · WK20250515