Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07182500

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

Led by Universiti Sains Malaysia · Updated on 2025-12-10

75

Participants Needed

2

Research Sites

10 weeks

Total Duration

On this page

Sponsors

U

Universiti Sains Malaysia

Lead Sponsor

S

Shanghai Jiao Tong University School of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Generally healthy adults
  • Scheduled to undertake a short-term round trip (less than 7 days) abroad
  • Able to complete study procedures
  • Willing to take intervention products
Not Eligible

You will not qualify if you...

  • Use of antibiotics, probiotics, hormones, immunosuppressants, biologics, or JAK inhibitors within 4 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Shanghai Jiao Tong University School of Medicine

Huangpu, Shanghai Municipality, China, 200001

Actively Recruiting

2

Universiti Sains Malaysia

George Town, Pulau Pinang, Malaysia, 11800

Not Yet Recruiting

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Research Team

M

Min Tze Liong, Ph.D.

CONTACT

J

Jie Yuan, M.Sc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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