Lactobacillus Plantarum and Hormonal Regulation in Obese Women

May 15, 2025 updated by: Wecare Probiotics Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 462000
        • Recruiting
        • Fuwai Central-China Cardiovascular Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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:

  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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic Group
Take Lactobacillus plantarum Lp90 at 30 billion CFU per day.
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).
Placebo Comparator: Placebo Group
Taking maltodextrin 3 g/day.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 1, 2, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 10, 2025

Primary Completion (Estimated)

September 10, 2025

Study Completion (Estimated)

December 10, 2025

Study Registration Dates

First Submitted

May 15, 2025

First Submitted That Met QC Criteria

May 15, 2025

First Posted (Actual)

May 23, 2025

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • WK20250515

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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