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.
Aged 18-65 years, regardless of gender;
Planning to undertake a short-term round-trip journey to Europe (within 7 days);
Able to understand and willing to comply with the study protocol, and to cooperate with study procedures;
Voluntarily sign the informed consent form before any study-related procedures are initiated.
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.;
Use of probiotic preparations, antibiotics, hormones, immunosuppressants, biological agents, or JAK inhibitors within 4 weeks;
Subjects with diagnosed or uncontrolled parasitic infections;
Patients receiving long-term medication for chronic diseases;
Parallel
Placebo
Other interventionDaily 6-drops of non-GMO corn starch in medium-chain triglyceride oil
Probiotic
Other interventionDaily 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)
Microbiota profiles of fecal samples in generally healthy adults upon administration of probiotic as assessed via metagenomics sequencing
Differences in microbiota abundance in fecal sample of generally healthy adults upon administration o probiotic compared to placebo
Respiratory symptoms duration and frequency in generally healthy adults upon administration of probiotic as assessed using questionnaire
Changes in duration and frequency of respiratory illnesses symptoms from generally healthy adults on probiotic or placebo after 7-days, via the use of standard clinical assessment questionnaire, scale 0-3 where higher scores indicate more severe symptoms.
Gastrointestinal symptoms in generally healthy adults upon administration of probiotic as assessed using questionnaire
Differences in duration and frequency of gastrointestinal symptoms upon administration of probiotic compared to placebo via the use of standard clinical assessment questionnaire, scale 0-3 where higher scores indicate more severe symptoms.
Allergy symptoms in generally healthy adults upon administration of probiotic as assessed using questionnaire
Differences in duration and frequency of allergy symptoms upon administration of probiotic compared to placebo via the use of standard clinical assessment questionnaire, scale 0-3 where higher scores indicate more severe symptoms.
Anxiety in generally healthy adults upon administration of probiotic as assessed using questionnaire
Differences in anxiety using the Generalized Anxiety Disorder Scale (GAD-7), having a scale of 0-3 where higher scores indicate more severe outcomes, upon administration of probiotic compared to placebo.
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Min-Tze LIONG
Lead sponsor
Universiti Sains Malaysia
Sponsor institution
Tsinghua University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
