Effects of BLa80 and LRa05 on the Gut Microbiota Metabolite Profile of Healthy Individuals

NCT ID: NCT07287306

Last Updated: 2025-12-17

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2026-11-15

Brief Summary

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Gut microbiota play a key role in polyphenol metabolism, participating in the breakdown of dietary components and producing various small molecule metabolites that affect human health. However, little is currently known about how gut microbes metabolize dietary compounds and produce bioactive metabolites. This study aims to use metabolomics to precisely identify food-derived metabolites in the blood to investigate whether probiotics (BLa80, LRa05) can enhance the breakdown of dietary components and improve their absorption and utilization in the human body.

Detailed Description

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Conditions

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Healthy Individuals

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LRa05

Each probiotic stick contained dextrin and 2 × 10¹⁰ CFU LRa05. Dosage: one stick per day.

Group Type EXPERIMENTAL

LRa05

Intervention Type DIETARY_SUPPLEMENT

The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).

Placebo

Each placebo stick contained 3 g of dextrin. Dosage: one stick per day.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).

BLa80

Each probiotic stick contained dextrin and 2 × 10¹⁰ CFU BLa80. Dosage: one stick per day.

Group Type EXPERIMENTAL

BLa80

Intervention Type DIETARY_SUPPLEMENT

The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).

Interventions

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Placebo

The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).

Intervention Type DIETARY_SUPPLEMENT

BLa80

The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).

Intervention Type DIETARY_SUPPLEMENT

LRa05

The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Male or female participants aged 18 to 60 years;
2. Healthy individuals;
3. Participants must provide written informed consent.

Exclusion Criteria

1. History of gastrointestinal surgery, other gastrointestinal diseases, metabolic disorders, immunodeficiency, hyperthyroidism, or cardiac or liver disease;
2. Use of immunosuppressants;
3. Pregnant or breastfeeding women;
4. Participants who have taken antibiotics or probiotics within the previous 3 months;
5. Planned surgery during the study period;
6. Patients with neurological disorders or psychiatric illness.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospttal, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yijun Zhu, Doctor

Role: primary

Other Identifiers

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WK20251120

Identifier Type: -

Identifier Source: org_study_id