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RECRUITING
NCT07182500
PHASE2

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

Sponsor: Universiti Sains Malaysia

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2025-10-16

Completion Date

2025-12-31

Last Updated

2025-12-10

Healthy Volunteers

Yes

Interventions

OTHER

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)

OTHER

Placebo

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