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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07287306
Enrollment
375
Registered
2025-12-17
Start date
2025-12-10
Completion date
2026-11-15
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Individuals

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.

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).

Sponsors

Wecare Probiotics Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Serum metabolomic profiles measured by HPLC-MS/MSBaseline (week 0), week 4, and week 8 post interventionUntargeted 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026