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

NCT07287306 | Recruiting

• 1 other identifier: WK20251120
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Individuals

Outcome Measures

Primary Outcomes (1)

• Serum metabolomic profiles measured by HPLC-MS/MS

  Untargeted serum metabolomic profiling will be performed using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) to assess changes in circulating metabolite concentrations over time.

  Baseline (week 0), week 4, and week 8 post intervention

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

BLa80

EXPERIMENTAL

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

Dietary Supplement: BLa80

LRa05

EXPERIMENTAL

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

Dietary Supplement: LRa05

Interventions

Placebo 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

BLa80 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

LRa05 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).

LRa05

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospttal, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 17, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

CN (1)