About this trial
Journeying along the historic Silk Road exposes travelers to dramatic dietary shifts, unfamiliar microbial environments, and the physical stresses of long-distance travel-all known to disrupt gut health and cause gastrointestinal complaints, including traveler's diarrhea and sleep disturbances. Such disruptions may also elevate the risk of acquiring antibiotic-resistant organisms.
This randomized, double-blind, placebo-controlled trial evaluated whether probiotic supplementation can help maintain gut microbial balance and support traveler well-being during trips to Silk Road regions. In addition to monitoring changes in gut microbiota composition, the study assessed gastrointestinal symptoms, sleep quality, anxiety levels, overall well-being, gut immune markers, functional profiles of the microbiome, and the presence of antibiotic resistance genes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Generally healthy adults
Scheduled to undertake a short-term round trip (less than 7 days) to abroad
Able to complete study procedures
Willing to take intervention products
Disqualifiers
Use of antibiotics, probiotics, hormones, immunosuppressants, biologics or JAK inhibitors within four weeks prior to study
Chronic or severe systemic diseases (including cardiovascular, hepatic, renal, malignant or psychiatric disorders)
Uncontrolled parasitic infections
Long-term use of corticosteroids, growth hormone, vitamin B12, lysine or inositol
Trial design
Parallel
Treatments tested in this trial
Probiotic
Other interventionDaily 6-drops of Bifidobacterium longum subsp. infantis M-63, B. breve M-16V, and B. longum BB536 in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1.5 × 109 CFU/day)
Placebo
Other interventionDaily 6-drops of non-GMO corn starch in medium-chain triglyceride oil
Treatment groups
Trial outcomes
Primary outcomes
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 of probiotic as compared to placebo
Secondary outcomes
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
Gastrointestinal metabolites in generally healthy adults upon administration of probiotic as assessed using LC-MS
Differences in concentrations of gastrointestinal metabolites upon administration of probiotic compared to placebo
Sponsors and contacts
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Universiti Sains Malaysia
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Collaborator