Probiotics, Respiratory and Intestinal Microbiome and Respiratory Tract Infections in Children
NCT ID: NCT03683927
Last Updated: 2018-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
120 participants
INTERVENTIONAL
2018-01-10
2020-03-10
Brief Summary
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In up to 80% of pneumonia cases the etiology is viral. Some viruses can persist up to 6 months after an acute infection. The time when viruses enter the body and whether they are commensals or only cause disease and are eliminated after an acute infection is unknown.
Modern techniques have identified diverse communities of microbiota in healthy and sick people, and viral communities associated in a close interaction. The acquisition and colonization by respiratory viruses and the role in health and disease in this niche that is the microbiome is unknown.
The role of probiotics in the prevention of respiratory disease and in the maintenance of homeostasis in the microbiota is poorly understood, and even more the probable relationship between the microbiota, the respiratory viruses that could be commensals or pathogens at the respiratory level, the time when children can be colonized, and their regulation with the administration of probiotics.
The aims of the study are to determine the changes in the intestinal and respiratory microbiota, the viruses that can be commensals or cause disease and the role of probiotics in the prevention of respiratory diseases during the first year of life.
A prospective, randomized, controlled clinical trial will be carried out making basic metagenomics studies (translational medicine). After informed consent, 120 newborns will be randomized into 2 groups, one will receive probiotics 4 times a week orally and the other a placebo consisting of sterile water 4 times a week. The clinical follow up will be done every 2 months until 1 year old, nasal washes and stool samples will be collected to determine the intestinal and respiratory microbiome. Multiplex polymerase chain reaction studies will be conducted to detect the presence of respiratory viruses and the time when the children acquire viruses that are commensal or only in the case of respiratory infection. The mothers will be asked to come for consult in case of respiratory infection and a nasal wash and stool sample will be taken. Descriptive, bivariate and multivariate statistics will be used to determine the associations between the microbiota, the viral metagenomics, the respiratory viruses and the risk of presenting or not respiratory infection in the group receiving probiotics compared to placebo.
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Detailed Description
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It is estimated that in up to 80% of pneumonia cases the etiology is viral. It has been reported that some viruses such as adenovirus or bocavirus can persist up to 6 months after an acute infection. The time when viruses enter the body and whether they are commensals of the respiratory tract or only cause disease and are eliminated after an acute infection is unknown.
Modern techniques have identified diverse communities of microbiota in healthy and sick people, and viral communities associated in a close interaction, which has changed concepts of pathogenesis of respiratory tract infections. The interaction of respiratory viruses, the acquisition and colonization by respiratory viruses and the role in health and disease in this niche that is the microbiome is not known.
The role of probiotics in the prevention of respiratory disease and in the maintenance of homeostasis in the microbiota is poorly studied, and even more the probable relationship between the microbiota, the viroma, the respiratory viruses that could be commensals or pathogens at the respiratory level, the time when children can be colonized, and their regulation with the administration of probiotics.
The aims of the study are to determine the changes in the intestinal and respiratory microbiota, the intestinal and respiratory viroma, the viruses that can be commensals or cause disease and the role of probiotics in the prevention of respiratory diseases during the first year of life.
Methods A prospective, randomized, controlled clinical trial will be carried out making basic metagenomics studies applied to the clinic (translational medicine). In this study the investigators plan to follow up a cohort of 120 children from newborns to one year of age. After informed consent, children will be randomized into 2 groups, one will receive probiotics 4 times a week orally and the other a placebo consisting of sterile water 4 times a week. The clinical follow up will be done every 2 months, where nasal washes and stool samples will be collected to determine the intestinal and respiratory microbiome and the viral metagenomics. Multiplex polymerase chain reaction studies will be conducted to detect the presence of respiratory viruses and detect the time when the children acquire viruses that are commensal or only in case of respiratory infection with manifestations of disease. The mothers will document and will be asked to come for consult in case of respiratory infection, in which samples of nasal washes will be taken to determine the virus or bacteria that could be causing the infection. Descriptive, bivariate and multivariate statistics will be used to determine the associations between the microbiota, the viral metagenomics, the respiratory viruses and the risk of presenting or not respiratory infection in the group receiving probiotics compared to placebo. A p\< 0.05 will be considered statistically significant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Probiotics
Probiotics consist on Bacillus clausii in a plastic vial that will be administered to the infant 4 times a week
Bacillus clausii
The probiotic (Bacillus clausii) will be administered 4 times a week to the infant
Placebo group
Sterile water contained in a plastic vial will be administered to the infant 4 times a week
Sterile water
The placebo group will receive sterile water 4 times a week
Interventions
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Bacillus clausii
The probiotic (Bacillus clausii) will be administered 4 times a week to the infant
Sterile water
The placebo group will receive sterile water 4 times a week
Eligibility Criteria
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Inclusion Criteria
* Vaginal or cesarean section delivery
* Informed consent of both parents to participate
Exclusion Criteria
* Co-morbidities
3 Hours
2 Days
ALL
Yes
Sponsors
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Hospital General de Mexico
OTHER_GOV
Universidad Nacional Autonoma de Mexico
OTHER
Responsible Party
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Rosa Maria Wong Chew
Professor B. Head of the Infectious Diseases Research Laboratory
Principal Investigators
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Rosa M Wong-Chew, MD, DSc
Role: PRINCIPAL_INVESTIGATOR
Facultad de Medicina, Universidad Nacional Autonoma de Mexico
Locations
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Rosa Maria Wong-Chew
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CONACYT PN 2015-01-878
Identifier Type: -
Identifier Source: org_study_id
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