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Clinical study for the characteristics of nasal and intestinal microflora and the effect of probiotic intervention in people with high exposure to PM2.5

Clinical study for the characteristics of nasal and intestinal microflora and the effect of probiotic intervention in people with high exposure to PM2.5

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002547
Enrollment
Unknown
Registered
2019-08-27
Start date
2019-10-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Flora disorder

Interventions

Sponsors

The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria of high exposure population: (1) Sanitation workers and traffic guides working in traffic pollution environment in Chengdu, age: 22 to 65 years old, male and female are not limited, fixed post working years >= 3 years, fixed place working time >= 8 hours; (2) there was no history of gastroenteritis in the past month; (3) no hormones and antibiotics were used in the past month; (4) no nasal spray or other probiotics (such as lactic acid bacteria, bifidobacterium, etc.) yoghurt and beverage were used in the past 3 months; (5) clinical examination of lip, throat, ear, nostril (especially anterior nostril) and neck, no lymph node enlargement, inflammation, polyp, mass, runny nose, etc; (6) no chronic constipation (defecation = 3 years, fixed place working time >= 8 hours; (2) there was no history of gastroenteritis in the past month; (3) no hormones and antibiotics were used in the past month; (4) no nasal spray or other probiotics (such as lactic acid bacteria, bifidobacterium, etc.) yoghurt and beverage were used in the past 3 months; (5) clinical examination of lip, throat, ear, nostril and neck (especially anterior nostril), no lymph node enlargement, inflammation, polyp, mass, runny nose, etc; (6) no chronic constipation (defecation < 3 times a week) and hemorrhoids.

Exclusion criteria

Exclusion criteria: (1) patients with a history of gastrointestinal surgery; (2) patients with a long history of drug use; (3) a history of smoking; (4) pregnancy and lactation; (5) those who could not understand and cooperate with the experimental process; (6) patients who had participated in other clinical trials in the past 1 month.

Design outcomes

Primary

MeasureTime frame
nasal microbiota structure;gut microbiota structure;

Secondary

MeasureTime frame
Pulmonary function;Follow-up record of respiratory and circulatory system diseases;GSRS;SF-36;COOP/WONCA chart;

Countries

China

Contacts

Public ContactFei Wang

The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

wangfei896@163.com+86 18980880213

Outcome results

None listed

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