RecruitingPhase 2NCT07182500

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


Sponsor

Universiti Sains Malaysia

Enrollment

75 participants

Start Date

Oct 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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

Exclusion Criteria7

  • 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

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Interventions

OTHERProbiotic

Daily 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)

OTHERPlacebo

Daily 6-drops of non-GMO corn starch in medium-chain triglyceride oil


Locations(2)

Shanghai Jiao Tong University School of Medicine

Huangpu, Shanghai Municipality, China

Universiti Sains Malaysia

George Town, Pulau Pinang, Malaysia

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NCT07182500


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