Lactobacillus Plantarum and Hormonal Regulation in Obese... | NCT06987279

Studies
Lactobacillus Plantarum and Hormonal Regulation in Obese Women

NCT06987279

Sponsor

Wecare Probiotics Co., Ltd.

Status

Recruiting

Last Update Posted

May 23, 2025Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Obesity, Women

Interventions

Probiotic
Maltodextrin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2025Estimated

Primary Completion Date

Sep 10, 2025Estimated

Completion Date

Dec 10, 2025Estimated

First Submitted Date

May 15, 2025

First Submission Date that Met QC Criteria

May 15, 2025

First Posted Date

May 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2025

Last Update Posted Date

May 23, 2025Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic Group	Experimental	Take Lactobacillus plantarum Lp90 at 30 billion CFU per day.	Dietary Supplement: Probiotic
Placebo Group	Placebo Comparator	Taking maltodextrin 3 g/day.	Dietary Supplement: Maltodextrin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotic	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).	Probiotic Group

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

Eligibility Module

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.

-

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.

-

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena