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Effects of probiotic Lacticaseibacillus paracasei strain Shirota on gastrointestinal adverse reactions and immunity function in tuberculosis patients

Effects of probiotic Lacticaseibacillus paracasei strain Shirota on gastrointestinal adverse reactions and immunity function in tuberculosis patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069665
Enrollment
Unknown
Registered
2023-03-22
Start date
2023-04-26
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Tuberculosis

Interventions

LcS intervention group:Drink milk drinks containing 10 billion LcS every day
Control group:Placebo

Sponsors

Medical College Of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 75 years, DOTS daily regimen (2HRZE/4HR, H = isoniazid, R = rifampicin, Z = pyrazinamide, E = ethambutol; Intensive treatment for the first two months, consolidation therapy for the next four months) ; 2. All participants will be asked to quit smoking and alcohol during the intervention, and must not take probiotics with foods such as yogurt and beverages; 3. They will be required to take the investigational product daily and comply with questionnaires and blood and stool samples.

Exclusion criteria

Exclusion criteria: 1. Patients with baseline liver dysfunction; 2. Pregnant or lactating women; 3. Hypersensitivity to cow's milk; 4. Tuberculosis outside the lungs; 5. Concurrent diabetes mellitus; 6. Severe kidney, heart, or intestinal disease; 7. With chronic inflammatory or autoimmune diseases or psychiatric disorders; 8. Frequent consumption of probiotics or fermented milk; 9. Taking medications or supplements that may affect the results of the study.

Design outcomes

Primary

MeasureTime frame
Gastrointestinal adverse reactions;

Secondary

MeasureTime frame
Intestinal flora;Antimicrobial peptides;NK activity;CD4+/CD8+;

Countries

China

Contacts

Public ContactWang Qiuzhen

Qingdao University

kevin_1971@126.com+86 137 0532 0918

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026