Lactobacillus Gasseri and Hormonal Regulation in Obese Women

March 25, 2026 updated by: Wecare Probiotics Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

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 Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 462000
        • Fuwai Central-China Cardiovascular Hospital

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) 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.

-

Exclusion Criteria:

(1) 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.

-

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
Placebo Comparator: Placebo Group
Taking maltodextrin 3 g/day.
Dietary supplement: Maltodextrin
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).
Experimental: Probiotic Group
Take Lactobacillus gasseri LG08 per day.
Dietary supplement: Probiotic
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).

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: Week 0 and Week 12
The serum estrogen content of the subjects before and after the intervention was detected by enzyme-linked immunosorbent assay.
Week 0 and Week 12

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 (Actual)

April 28, 2025

Primary Completion (Actual)

July 21, 2025

Study Completion (Actual)

October 25, 2025

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WK20260325

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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