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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Probiotic

    Other intervention

    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)

  • Placebo

    Other intervention

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

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: ProbioticExperimental treatment 1 intervention

Trial outcomes

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

Time frame
7 days

Secondary outcomes

1

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

Changes in duration and frequency of respiratory illnesses symptoms from generally healthy adults on probiotic or placebo after 7-days, via the use of standard clinical assessment questionnaire, scale 0-3 where higher scores indicate more severe symptoms

Time frame
7 days
2

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

Differences in duration and frequency of gastrointestinal symptoms upon administration of probiotic compared to placebo via the use of standard clinical assessment questionnaire, scale 0-3 where higher scores indicate more severe symptoms

Time frame
7 days
3

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

Differences in duration and frequency of allergy symptoms upon administration of probiotic compared to placebo via the use of standard clinical assessment questionnaire, scale 0-3 where higher scores indicate more severe symptoms

Time frame
7 days
4

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

Differences in concentrations of gastrointestinal metabolites upon administration of probiotic compared to placebo

Time frame
7 days

Other outcomes

Sponsors and contacts

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Universiti Sains Malaysia

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Collaborator