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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversiti Sains Malaysia

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

Qualifiers

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

Treatments tested in this trial

  • Probiotic
  • Placebo

Treatment groups

75 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universiti Sains Malaysia

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Collaborator