Clinical Trial

The Effect of Bifidobacterium Probiotics on Gut Microbiota Changes in Healthy Adults During Short-term Travel Along the Silk Road

Recruiting Phase 2
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Record status
This record was last updated December 10, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-15.
Status change: Not Yet Recruiting → Recruiting 2025-12-02
Trial Details
NCT Number NCT07182500
Lead Sponsor Universiti Sains Malaysia
Collaborators: Shanghai Jiao Tong University School of Medicine
Conditions Healthy Adult Volunteer
Enrollment 75 participants
Start Date 2025-10-16
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-10