The Effect of Bifidobacterium Probiotics on Gut Microbiota Changes in Healthy Adults During Short-term Travel Along the Silk Road
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Healthy Adult Volunteer
In brief
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.
Key facts
- Study ID
- NCT07182500
- Run by
- Universiti Sains Malaysia
- People needed
- 75
- Starts
- 2025-10-16
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-12-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Major surgery within one month
- Allergy to probiotic components
- Other conditions deemed inappropriate by investigators
Where it is running
- Shanghai Jiao Tong University School of Medicine — Huangpu, Shanghai Municipality, China (enrolling)
- Universiti Sains Malaysia — George Town, Pulau Pinang, Malaysia
Full record on ClinicalTrials.gov
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