Stress-buffering and Sleep Disturbance-resilient Effects of a Dual Bifidobacterium Longum Combination Under Short-term Travel

NCT07511855 | Not Yet Recruiting Phase 2

• 1 other identifier: HK-2526-FSN-155
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of a dual Bifidobacterium longum probiotic formulation (dipro-O and dipro-X) on sleep quality, stress responses, and gut microbiota stability in healthy adults during short-term travel. Using a randomized, double-blind, placebo-controlled design, the study investigates whether probiotic supplementation can enhance sleep resilience, buffer stress, and modulate microbiome and physiological responses under travel-related environmental changes.

Conditions

Healthy

Keywords

probiotic; Bifidobacterium; short term travel; sleep; gut microbiota

Outcome Measures

Primary Outcomes (2)

• Sleep quality during short-term travel following probiotic intervention compared with placebo as assessed via questionnaire

  Changes in sleep quality from generally healthy adults during short-term travel following probiotic intervention compared with placebo, via the Pittsburgh Sleep Quality Index (PSQI) questionnaire, scale 0-3 where higher scores indicate poorer sleep quality.

  10-days

• Sleep quality during short-term travel following probiotic intervention compared with placebo as assessed using wearable device monitoring.

  Changes in sleep- and cardiac-related physiological parameters from generally healthy adults during short-term travel following probiotic intervention compared with placebo as assessed using the Huawei Band 10 NFC edition.

  10-days

Secondary Outcomes (5)

• General well being in generally healthy adults upon administration of probiotic or placebo as assessed using questionnaire

  10-days

• Psychological well being in generally healthy adults upon administration of probiotic or placebo as assessed using questionnaire

  10-days

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

  10-days

• Gastrointestinal immune biomarkers in generally healthy adults upon administration of probiotic or placebo as assessed using Enzyme-Linked Immunosorbent Assay (ELISA)

  10-days

• Salivary stress biomarkers in generally healthy adults upon administration of probiotic or placebo as assessed using Enzyme-Linked Immunosorbent Assay (ELISA)

  10-days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Daily one sachet containing maltodextrin

Dietary Supplement: Placebo

Probiotic

ACTIVE COMPARATOR

Daily one sachet containing Bifidobacterium longum subsp. longum dipro-O and Bifidobacterium longum subsp. longum dipro-X, with a combined total dose of 5 × 10⁹colony-forming units (CFU) and maltodextrin as carrier

Dietary Supplement: Probiotic

Interventions

Placebo DIETARY_SUPPLEMENT

Daily one sachet containing maltodextrin

Placebo

Probiotic DIETARY_SUPPLEMENT

Daily one sachet containing Bifidobacterium longum subsp. longum dipro-O and Bifidobacterium longum subsp. longum dipro-X, with a combined total dose of 5 × 10⁹colony-forming units (CFU) and maltodextrin as carrier

Probiotic

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to participate in this study and able to provide written informed consent before any study procedures are initiated.
• Able and willing to comply with all study procedures as required by the protocol, including continuous wearable device use, saliva and stool sample collection, and completion of questionnaire assessments.
• Willing to accept randomization and group allocation as determined by the study protocol.

You may not qualify if:

• Known use of antibiotics or systemic corticosteroids within 4 weeks prior to enrollment.
• Use of probiotic supplements within 4 weeks prior to enrollment.
• Planned use of any probiotic supplements during the study period.
• Known history or current presence of major endocrine disorders, active inflammatory bowel disease or other severe gastrointestinal diseases, or severe sleep disorders requiring treatment adjustment.
• Pregnant or intend to get pregnant, or lactating women.
• Known allergy to any probiotic products.
• Participation in any other clinical interventional study involving drugs, dietary supplements, probiotics, or prebiotics within the past three months.
• Or those who, according to the researcher's judgment, may have inadequate adherence or are unable to complete the study protocol.

Sponsors & Collaborators

• Min-Tze LIONG: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Kowloon, Hong Kong

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Daisy Zhao, Ph.D.

CONTACT

3400 8680; daisydy.zhao@polyu.edu.hk

Jie Yuan, M.Sc.

CONTACT

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: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)