The Effect of Probiotics on Gut Microbiota Changes in Healthy Chinese Adults During Short-Term European Travel: A Randomised, Double-Blind, Placebo-Controlled Clinical Trial
Placebo: Daily 6-drops of non-GMO corn starch in medium-chain triglyceride oil
Probiotic: Daily 6-drops of Bifidobacterium animalis subsp. lactis B94, Lacticaseibacillus helveticus R0052 in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1.5 × 109 CFU/day)
Study summary
This study aims to evaluate the efficacy of a probiotic complex (containing Bifidobacterium animalis subsp. lactis B94 and Lacticaseibacillus helveticus R0052) in maintaining gut microbiota homeostasis and supporting physiological and psychological stability among healthy Chinese adults during short-term travel to Europe.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion criteria:
1. Aged 18-65 years, regardless of gender;
2. Planning to undertake a short-term round-trip journey to Europe (within 7 days);
3. Able to understand and willing to comply with the study protocol, and to cooperate with study procedures;
4. Voluntarily sign the informed consent form before any study-related procedures are initiated.
Exclusion criteria:
1. Diseases that may affect the evaluation of trial results, such as immune dysfunction, severe renal/hepatic dysfunction, severe cardiovascular disease, malignant tumors, acute or chronic infections, etc.;
2. Use of probiotic preparations, antibiotics, hormones, immunosuppressants, biological agents, or JAK inhibitors within 4 weeks;
3. Subjects with diagnosed or uncontrolled parasitic infections;
4. Patients receiving long-term medication for chronic diseases;
5. Patients with severe organic lesions in the thyroid, heart, brain, lungs, kidneys, or musculoskeletal system;
6. Patients with a history of or currently diagnosed mental illness;
7. Patients on long-term corticosteroid therapy;
8. Use of growth hormone, γ-aminobutyric acid (GABA), lysine, inositol, or vitamin B12;
9. Presence of uncontrolled, clinically significant laboratory abnormalities that may affect data interpretation or subject participation;
10. Participation in other clinical intervention studies involving drugs, dietary supplements, probiotics, or prebiotics within the past 4 weeks;
11. Presence of severe infections or major trauma deemed by the investigator to potentially affect outcomes, or having undergone moderate to major surgery within the past month;
12. Known allergy to any component of the probiotic product;
13. Subjects deemed unsuitable for participation by the investigator for any other reason.
Primary outcome measure(s)
Microbiota profiles of fecal samples in generally healthy adults upon administration of probiotic as assessed via metagenomics sequencing — 7 days Differences in microbiota abundance in fecal sample of generally healthy adults upon administration o probiotic compared to placebo
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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