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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
China
Shanghai Jiao Tong University School of Medicine
RECRUITING
Huangpu
Malaysia
Universiti Sains Malaysia
NOT_YET_RECRUITING
George Town
Contact Information
Primary
Min Tze Liong, Ph.D.
mintze.liong@usm.my
6046532114
Backup
Jie Yuan, M.Sc.
peanut.yuan@diprobio.com
822137027899
Time Frame
Start Date: 2025-10-16
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 75
Treatments
Placebo_comparator: Placebo
Daily 6-drops of non-GMO corn starch in medium-chain triglyceride oil
Experimental: Probiotic
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)
Related Therapeutic Areas
Sponsors
Leads: Universiti Sains Malaysia
Collaborators: Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov