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

Effects of BLa80 and LRa05 on the Gut Microbiota Metabolite Profile of Healthy Individuals: A Randomized, Double-Blind, Placebo-Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Individuals
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: BLa80; Dietary supplement: LRa05

• Study Type: Interventional
• Enrollment (Estimated): 375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • The First Affiliated Hospttal, Sun Yat-sen University
      • Contact: Yijun Zhu, Doctor; Phone Number: +86 13922101450; Email: zhuyj67@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Each placebo stick contained 3 g of dextrin. Dosage: one stick per day.	Dietary supplement: 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).
Experimental: BLa80; Each probiotic stick contained dextrin and 2 × 10¹⁰ CFU BLa80. Dosage: one stick per day.	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).
Experimental: LRa05; Each probiotic stick contained dextrin and 2 × 10¹⁰ CFU LRa05. Dosage: one stick per day.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: WK20251120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No