ClinicalTrials.gg
RecruitingNCT07287306Updated Dec 17, 2025

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

An interventional study of Placebo and BLa80 in Healthy Individuals, sponsored by Wecare Probiotics Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-17.

Sponsored by Wecare Probiotics Co., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Dec 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
375
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Individuals
03

In context

Lead sponsor

Wecare Probiotics Co., Ltd. is the lead sponsor of 67 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. History of gastrointestinal surgery, other gastrointestinal diseases, metabolic disorders, immunodeficiency, hyperthyroidism, or cardiac or liver disease;
  2. Use of ;
  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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
375 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

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

    Dietary Supplement: Placebo

  • Experimental
    BLa80

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

    Dietary Supplement: BLa80

  • Experimental
    LRa05

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

    Dietary Supplement: LRa05

Interventions

  • Dietary supplementPlacebo

    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).

  • Dietary supplementBLa80

    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).

  • Dietary supplementLRa05

    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).

06

What researchers measure

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.

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

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospttal, Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07287306
Responsible party
Sponsor
First posted
Dec 17, 2025
Start date
Dec 10, 2025
Primary completion
Jun 20, 2026 (estimated)
Completion
Nov 15, 2026 (estimated)
Last update
Dec 17, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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Studies of the drug tested here: BLA80

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