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

NCT07182500 | Recruiting Phase 2

• 1 other identifier: SJUPN-2025-013-HY1-KS2
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Healthy Adult Volunteer

Keywords

probiotc; travel; Silk Road

Outcome Measures

Primary Outcomes (1)

• Microbiota profiles of fecal samples in generally healthy adults upon administration of probiotic as assessed via metagenomics sequencing

  Differences in microbiota abundance in fecal sample of generally healthy adults upon administration of probiotic as compared to placebo

  7 days

Secondary Outcomes (7)

• Respiratory symptoms duration and frequency in generally healthy adults upon administration of probiotic as assessed using questionnaire

  7 days

• Gastrointestinal symptoms in generally healthy adults upon administration of probiotic as assessed using questionnaire

  7 days

• Allergy symptoms in generally healthy adults upon administration of probiotic as assessed using questionnaire

  7 days

• Gastrointestinal metabolites in generally healthy adults upon administration of probiotic as assessed using LC-MS

  7 days

• Anxiety in generally healthy adults upon administration of probiotic as assessed using questionnaire

  7 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Probiotic

EXPERIMENTAL

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: Probiotic

Interventions

Probiotic OTHER

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)

Probiotic

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (2)

Shanghai Jiao Tong University School of Medicine

Huangpu, Shanghai Municipality, 200001, China

RECRUITING

Universiti Sains Malaysia

George Town, Pulau Pinang, 11800, Malaysia

NOT YET RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Meiqin Cai, MD.

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Tze Liong, Ph.D.

CONTACT

6046532114; mintze.liong@usm.my

Jie Yuan, M.Sc.

CONTACT

822137027899; peanut.yuan@diprobio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 19, 2025
• Study Start: October 16, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1); CN (1)