NCT07384260

Brief 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 Europe.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
9mo left

Started Feb 2026

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Feb 2026Jan 2027

First Submitted

Initial submission to the registry

January 19, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

January 19, 2026

Last Update Submit

January 28, 2026

Conditions

Healthy Adult

Keywords

probioticinternational travel

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 o probiotic compared to placebo

    7 days

Secondary Outcomes (6)

  • 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

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

    7 days

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

    7 days

  • +1 more secondary outcomes

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

Other: Probiotic

Interventions

PlaceboOTHER

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

Placebo
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)

Probiotic

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tsinghua University Science and Technology

Haidian, Beijing Municipality, 100080, China

Location

Universiti Sains Malaysia

Pulau Pinang, Pulau Pinang, 11800, Malaysia

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ai Zhou, Ph.D.

    Tsinghua University Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Jie, M.Sc.

CONTACT

822137027899peanut.yuan@diprobio.com

Min Tze Liong, Ph.D.

CONTACT

6046532114mintze.liong@usm.my

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
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 19, 2026

First Posted

February 3, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)CN(1)