Probiotics' Effects on Hormones, Body and Mood in Obese Women

NCT ID: NCT07013409

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity, Women

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probiotic Group

Take 30 billion CFU of complex probiotics every day (Lacticaseibacillus rhamnosus LRa05: Limosilactobacillus reuteri LR08= 1:1).

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

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 Group

Taking maltodextrin 3 g/day.

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type 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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fei Xu, Doctor

Role: CONTACT

18623716648 ext. +86

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fei Xu, Doctor

Role: primary

18623716648 ext. +86

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WK20250603

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of Synbiotics on Obesity
NCT06578143 NOT_YET_RECRUITING PHASE2
Probiotics for Weight Loss
NCT04897698 COMPLETED NA