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Healthy AdultPhase 2The Effect ofNCT07384260

The Effect of Probiotics on Gut Microbiota Changes in Healthy Chinese Adults During Short-Term European Travel: A Randomised, Double-Blind, Placebo-Controlled Clinical Trial

A Phase 2 study testing Probiotic in people with Healthy Adult, run by Min-Tze LIONG at 2 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the efficacy of a probiotic complex (containing Bifidobacterium animalis subsp. lactis B94 and Lacticaseibacillus helveticus R0052) in maintaining gut microbiota homeostasis and supporting physiological and psychological stability among healthy Chinese adults during short-term travel to… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adult
What is being tested?
Probiotic
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
2 sitesin 2 countries
Study dates
1 Feb 2026to 31 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged 18-65 years, regardless of gender;
  • Planning to undertake a short-term round-trip journey to Europe (within 7 days);
  • Able to understand and willing to comply with the study protocol, and to cooperate with study procedures;
  • Voluntarily sign the informed consent form before any study-related procedures are initiated.

Who cannot join

  • Diseases that may affect the evaluation of trial results, such as immune dysfunction, severe renal/hepatic dysfunction, severe cardiovascular disease, malignant tumors, acute or chronic infections, etc.;
  • Use of probiotic preparations, antibiotics, hormones, immunosuppressants, biological agents, or JAK inhibitors within 4 weeks;
  • Subjects with diagnosed or uncontrolled parasitic infections;
  • Patients receiving long-term medication for chronic diseases;
  • Patients with severe organic lesions in the thyroid, heart, brain, lungs, kidneys, or musculoskeletal system;
  • Patients with a history of or currently diagnosed mental illness;
Show all 13Show fewer
  • Patients on long-term corticosteroid therapy;
  • Use of growth hormone, γ-aminobutyric acid (GABA), lysine, inositol, or vitamin B12;
  • Presence of uncontrolled, clinically significant laboratory abnormalities that may affect data interpretation or subject participation;
  • Participation in other clinical intervention studies involving drugs, dietary supplements, probiotics, or prebiotics within the past 4 weeks;
  • Presence of severe infections or major trauma deemed by the investigator to potentially affect outcomes, or having undergone moderate to major surgery within the past month;
  • Known allergy to any component of the probiotic product;
  • Subjects deemed unsuitable for participation by the investigator for any other reason.

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Min Tze Liong, Ph.D. contact

6046532114

mintze.liong@usm.my

2 sites in 2 countries

China1 site
  • Tsinghua University Science and Technology

    Haidian, Beijing Municipality, 100080

    Yuan Jie, M.Sc., 822137027899, peanut.yuan@diprobio.com

Other trials in China

Malaysia1 site
  • Universiti Sains Malaysia

    Pulau Pinang, Pulau Pinang, 11800

    Min Tze Liong, Ph.D, 6046532114, mintze.liong@usm.my

Other trials in Malaysia

About this study

This study aims to evaluate the efficacy of a probiotic complex (containing Bifidobacterium animalis subsp. lactis B94 and Lacticaseibacillus helveticus R0052) in maintaining gut microbiota homeostasis and supporting physiological and psychological stability among healthy Chinese adults during short-term travel to Europe.

Read the detailed description

With rising living standards, travel has become a common leisure activity. However, environmental changes, altered dietary habits, and disruptions to circadian rhythms during travel can significantly affect gut microbiota, potentially leading to various health issues. Dietary shifts are a primary driver of these alterations; the introduction of unfamiliar foods and beverages exposes the gut to foreign bacterial strains that compete with indigenous microbiota, increasing the risk of dysbiosis. This imbalance may manifest as gastrointestinal disturbances such as traveler's diarrhea or constipation, often associated with high-fat and low-fiber diets. In addition to dietary factors, travel-related stress, jet lag, and variations in hygiene conditions further influence microbial homeostasis. Growing evidence underscores a close relationship between gut microbiota and immune function, indicating that dysbiosis may compromise immune defenses and heighten susceptibility to respiratory infections and allergic responses triggered by novel environmental exposures.

Probiotics, defined as live microorganisms that confer health benefits when administered in adequate amounts, have gained considerable attention for their potential to promote human health. Predominantly derived from the *Lactobacillus* and *Bifidobacterium* genera, these beneficial microbes support gut health by modulating microbial composition, enhancing immune function, and improving digestive processes. Numerous studies have demonstrated their effectiveness in alleviating gastrointestinal disorders and reducing infection risk through immune system reinforcement. In addition, the capacity of probiotics to influence the gut-brain axis highlights their potential role in supporting mental health.

To ensure both safety and efficacy, this study employs *Bifidobacterium animalis* subsp. *lactis* B94 and *Lacticaseibacillus helveticus* R0052. Strain B94 has been clinically validated for improving bowel regularity and alleviating gastrointestinal discomfort through mechanisms such as short-chain fatty acid (SCFA) production, pathogen inhibition, and enhancement of intestinal barrier function. Strain R0052 is well recognized for its tolerability and its ability to shorten the duration of antibiotic-associated diarrhea while modulating immune responses. Moreover, R0052 has been shown to reduce psychological distress under stressful conditions, suggesting a regulatory role within the gut-brain axis. The combined use of these strains is therefore expected to promote microbiota stability and support overall health during the short-term physiological and psychological stress associated with travel.

The present study builds upon findings from a previous randomized controlled trial involving travelers to Japan. That trial demonstrated that short-term probiotic supplementation significantly enhanced gut microbiota resilience and improved both physiological and psychological homeostasis. Compared with the control group, participants receiving probiotics exhibited smaller fluctuations in microbial composition and achieved a more rapid return to baseline following travel. Lower incidences of gastrointestinal discomfort were reported, alongside improvements in anxiety, fatigue, and mood stability. Collectively, these results suggest that short-term probiotic intervention represents a practical and effective strategy for supporting health and well-being during periods of rapid environmental and lifestyle change.

Conditions
Healthy Adult
Being tested
Placebo, Probiotic
Keywords
probiotic, international travel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboOther

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

  • ProbioticOther

    Daily 6-drops of Bifidobacterium animalis subsp. lactis B94, Lacticaseibacillus helveticus R0052 in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1.5 × 109 CFU/day)

Study groups in NCT07384260
Study groupRoleWhat they receive
PlaceboPlacebo comparatorDaily 6-drops of non-GMO corn starch in medium-chain triglyceride oil
Receives: Other: Placebo
ProbioticExperimentalDaily 6-drops of Bifidobacterium animalis subsp. lactis B94, Lacticaseibacillus helveticus R0052 in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1.5 × 109 CFU/day)
Receives: Other: Probiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 o probiotic compared to placebo

    Measured: 7 days

Secondary outcomes (6)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 7 days

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

    Differences in anxiety using the Generalized Anxiety Disorder Scale (GAD-7), having a scale of 0-3 where higher scores indicate more severe outcomes, upon administration of probiotic compared to placebo.

    Measured: 7 days

  5. Sleep quality in generally healthy adults upon administration of probiotic as assessed using questionnaire

    Differences in sleep quality using the Pittsburgh Sleep Quality Index (PSQI), having a scale of 0-3 where higher scores indicate more severe outcomes, upon administration of probiotic compared to placebo.

    Measured: 7 days

  6. General well being in generally healthy adults upon administration of probiotic as assessed using questionnaire

    Differences in general well being using the World Health Organization Five Well-Being Index (WHO-5), having a scale of 0-5 where higher scores indicate better well being, upon administration of probiotic compared to placebo.

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07384260
Sponsor's protocol ID
THU-01-2025-1092
Acronym
The Effect of
Status last verified
Jan 2026
First submitted
19 Jan 2026
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Probiotic in people with Healthy Adult, run by Min-Tze LIONG at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China, Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuan Jie, M.Sc. (822137027899, peanut.yuan@diprobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiota profiles of fecal samples in generally healthy adults upon administration of probiotic as assessed via metagenomics sequencing (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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