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NCT Number: NCT07287306

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

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.

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Key information

Conditions

Healthy Individuals

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospttal, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Yijun Zhu, Doctor

CONTACT

[email protected]

13922101450 ext. +86

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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).

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).

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).

Primary outcomes

  1. Serum metabolomic profiles measured by HPLC-MS/MS

    Time frame: Baseline (week 0), week 4, and week 8 post intervention

    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.

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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