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Recruiting NCT07287306

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

No phase Interventional Healthy Individuals

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, BLa80, LRa05.
Who it may be relevant to
Registry conditions: Healthy Individuals. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 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).
  • 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).
  • 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).

Primary outcome measures

  • Serum metabolomic profiles measured by HPLC-MS/MS [Time frame: Baseline (week 0), week 4, and week 8 post intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospttal, Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07287306 · WK20251120

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗