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

Phase 1

• Conditions: Flora disorder

• Registration Number: ITMCTR1900002547
• Lead Sponsor: The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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 times a week) and hemorrhoids.
Inclusion criteria of low exposure population:
(1) the staff of Chengdu Urban Environmental Hygiene Administration Bureau working indoors and the staff of Chengdu Traffic Administration Bureau working indoors (with air conditioning), age: 22 to 65 years old, male and female; 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 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

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nasal microbiota structure;gut microbiota structure;

Secondary Outcome Measures

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