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Study protocol
Characteristics of nasal and intestinal microbiota and effects of probiotics intervention in highly exposed people with PM2.5: a randomized, double-blind, placebo-controlled clinical study
Zhenxing Wang
Chengdu University of Traditional Chinese Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-6832-9652
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial to human health, and certain health-related problems may be addressed by effective microecosystem regulation. Recent studies have confirmed that probiotics may reduce the incidence of respiratory diseases. However, few studies have investigated probiotic treatment outcomes in subjects exposed to high concentrations of PM2.5.
Methods: This study is designed as a prospective, 2×2 factorial, randomized, participants- and assessor-blinded, placebo-controlled trial. One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China will be treated with either probiotics or placebo over 4 consecutive weeks. The primary outcome will be 16SrRNA sequencing assay data from nasal and intestinal secretions. Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life. Results will be analysed to assess differences in clinical efficacy between groups. Six-month follow-up examinations will evaluate the long-term value of probiotics on cardiovascular and respiratory disease end-point events.
Discussion: We will explore the characteristics of nasal and intestinal microbiota in a population with high exposure to PM2.5. Probiotics and placebo interventions will be tested for efficacy in microbial balance regulation, effects on lung and physical functions, and quality of life improvement. This study is expected to provide reliable evidence to support the widespread promotion of probiotics in clinical practice for the protection of individuals with high exposure to PM2.5.
Keywords
Air pollution, PM2.5 high exposure, respiratory system, nasal and intestinal microbiota, probiotic
Figure 1
Due to technical limitations, Table 1 is available in the Supplementary Files.
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CURRENT STATUS: Published
Version 1
Posted 20 Dec, 2019
Published
On 14 Oct, 2020
No community comments so far
Review #2 received
Received 12 Mar, 2020
Reviewer #2 agreed
On 11 Mar, 2020
Review #1 received
Received 30 Jan, 2020
Reviewer #1 agreed
On 09 Jan, 2020
Reviewers invited
Invitations sent on 07 Jan, 2020
Editor assigned
On 30 Dec, 2019
Submission checks complete
On 20 Dec, 2019
First submitted
On 16 Dec, 2019
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Characteristics of nasal and intestinal microbiota and effects of probiotics intervention in highly exposed people with PM2.5: a randomized, double-blind, placebo-controlled clinical study
Zhenxing Wang
Chengdu University of Traditional Chinese Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-6832-9652
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 1
Posted 20 Dec, 2019
Published
On 14 Oct, 2020
No community comments so far
Review #2 received
Received 12 Mar, 2020
Reviewer #2 agreed
On 11 Mar, 2020
Review #1 received
Received 30 Jan, 2020
Reviewer #1 agreed
On 09 Jan, 2020
Reviewers invited
Invitations sent on 07 Jan, 2020
Editor assigned
On 30 Dec, 2019
Submission checks complete
On 20 Dec, 2019
First submitted
On 16 Dec, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background: Extended exposure to high concentrations of PM2.5 changes the human microbiota profile, which in turn may increase morbidity and mortality due to respiratory system damage. A balanced microecosystem is crucial to human health, and certain health-related problems may be addressed by effective microecosystem regulation. Recent studies have confirmed that probiotics may reduce the incidence of respiratory diseases. However, few studies have investigated probiotic treatment outcomes in subjects exposed to high concentrations of PM2.5.
Methods: This study is designed as a prospective, 2×2 factorial, randomized, participants- and assessor-blinded, placebo-controlled trial. One hundred and twenty eligible volunteers recruited from October 2019 to July 2020 in downtown Chengdu, China will be treated with either probiotics or placebo over 4 consecutive weeks. The primary outcome will be 16SrRNA sequencing assay data from nasal and intestinal secretions. Secondary outcomes will be pulmonary function, score on a gastrointestinal symptom rating scale, COOP/WONCA charts, and the Short-Form Health Survey 36 for quality of life. Results will be analysed to assess differences in clinical efficacy between groups. Six-month follow-up examinations will evaluate the long-term value of probiotics on cardiovascular and respiratory disease end-point events.
Discussion: We will explore the characteristics of nasal and intestinal microbiota in a population with high exposure to PM2.5. Probiotics and placebo interventions will be tested for efficacy in microbial balance regulation, effects on lung and physical functions, and quality of life improvement. This study is expected to provide reliable evidence to support the widespread promotion of probiotics in clinical practice for the protection of individuals with high exposure to PM2.5.
Figure 1
Due to technical limitations, Table 1 is available in the Supplementary Files.