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Effect of Bifidobacterium longum subsp. longum Combination Intervention on Stress Status and Related Health Outcomes: A Randomized, Double-Blind, Placebo-Controlled Clinical Study

Effect of Bifidobacterium longum subsp. longum Combination Intervention on Stress Status and Related Health Outcomes: A Randomized, Double-Blind, Placebo-Controlled Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126770
Enrollment
Unknown
Registered
2026-06-15
Start date
2026-06-20
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perceived stress and mental status

Interventions

Probiotic group:Bifidobacterium longum subspecies combination (dipro-O + dipro-X), 5×10^9 CFU per bag, once daily, 1 bag each time, oral administration, for 8 consecutive weeks
Placebo group:Placebo (erythritol, xylitol, blueberry juice powder, etc.), 0 CFU per bag, once daily, 1 bag each time, orally, for 8 consecutive weeks

Sponsors

Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–65 years; 2. PSS-10 score >= 14; 3. Voluntarily participate in this study and sign written informed consent before any study procedures begin.

Exclusion criteria

Exclusion criteria: 1. Use of probiotic supplements or probiotic-containing products within 4 weeks before enrollment; 2. Use of antibiotics or systemic glucocorticoids within 4 weeks before enrollment; 3. Current or previous diagnosis of psychiatric disorders (e.g., schizophrenia, epilepsy, major depressive disorder, etc.), major endocrine system diseases, active inflammatory bowel disease or other severe gastrointestinal disorders, or severe sleep disturbances requiring treatment adjustment; 4. Use of medications or dietary supplements that may affect the brain-gut axis, sleep, mood, or stress status assessment within 4 weeks before enrollment, including but not limited to sedative-hypnotics, anxiolytics, antidepressants, antipsychotics, mood stabilizers, and supplements with sleep-inducing, sedative, or stress-relieving effects (e.g., magnesium-containing supplements); 5. Pregnant or breastfeeding women; 6. Known allergy to the study product or any of its components; 7. Smoking or alcohol consumption on the day of the visit or within 48 hours before the visit; 8. Participation in other clinical intervention studies on drugs, dietary supplements, probiotics, or prebiotics within the past 3 months; 9. Insufficient compliance as judged by the investigator to complete sample collection or study-related documentation as required by the study protocol.

Design outcomes

Primary

MeasureTime frame
Stress status score;

Secondary

MeasureTime frame
Sleep quality score;Quality of life score;Gut microbiota;Gut stress biomarkers;Gut immune markers;

Countries

China

Contacts

Public ContactLi Huajun

Dalian Medical University

18817617918@163.com+86 411 8611 0282

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026