Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Probiotics, Respiratory and Intestinal Microbiome and Respiratory Tract Infections in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03683927
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
Hospital General de Mexico
Information provided by (Responsible Party):
Rosa Maria Wong Chew, Universidad Nacional Autonoma de Mexico

Brief Summary:

Pneumonia and diarrhea are the most frequent causes of infectious diseases in children under 5 years of age worldwide, responsible for 1.5 million deaths annually.

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.


Condition or disease Intervention/treatment Phase
Respiratory Infections in Children Combination Product: Bacillus clausii Other: Sterile water Phase 1

Detailed Description:

Pneumonia and diarrhea are the 2 most frequent causes of infectious diseases in children under 5 years of age worldwide, responsible for 1.5 million deaths annually. In 2013, they corresponded to 15% and 9%, respectively, of the 6.3 million deaths in children under 5 years of age. In our country according to the Ministry of Health, acute respiratory infections are the leading cause of disease nationwide with 27,493, 239 cases reported in 2014 in which pneumonia ranks 19th in the top 20 causes of disease with 174,748 cases, of which 51,893 cases (29%) are in children under 5 years of age, and 21,404 cases (12%) in children under 1 year old; in 2015, 148,140 cases of pneumonia were reported.

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Impact of Probiotics in the Respiratory and Gastrointestinal Microbiome and Its Role in Respiratory Tract Infections in Children
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : January 9, 2020
Estimated Study Completion Date : March 10, 2020

Arm Intervention/treatment
Experimental: Probiotics
Probiotics consist on Bacillus clausii in a plastic vial that will be administered to the infant 4 times a week
Combination Product: Bacillus clausii
The probiotic (Bacillus clausii) will be administered 4 times a week to the infant

Placebo Comparator: Placebo group
Sterile water contained in a plastic vial will be administered to the infant 4 times a week
Other: Sterile water
The placebo group will receive sterile water 4 times a week




Primary Outcome Measures :
  1. Number of respiratory infections in the first year of life [ Time Frame: 1 year ]
    Follow up of the infants will be performed every 2 months during 1 year to look at the incidence of respiratory tract infections in each arm


Secondary Outcome Measures :
  1. Rates of bacterial phyla in nasal and intestinal washes [ Time Frame: 1 year ]
    Nasal washes and stool samples will be taken and analyzed for the microbiome. The proportion of phyla will be compared between the probiotic and placebo groups.

  2. Number of viruses detected in nasal washes during the follow up [ Time Frame: 1 year ]
    Nasal washes will be taken every 2 months during 1 year to detect by multiplex polymerase chain reaction viruses that could be in the nasopharynx of the children



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Heathy term newborns
  • Vaginal or cesarean section delivery
  • Informed consent of both parents to participate

Exclusion Criteria:

  • Preterm newborns
  • Co-morbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683927


Contacts
Layout table for location contacts
Contact: Rosa M Wong-Chew, MD, DSc 5255 56232300 ext 43193 rmwong@unam.mx

Locations
Layout table for location information
Mexico
Rosa Maria Wong-Chew Recruiting
Mexico city, Mexico, 04510
Contact: Rosa M Wong-Chew, MD    5556232300    rmwong@unam.mx   
Principal Investigator: Bogart Espinosa Torres Torija, MD         
Sub-Investigator: Brenda Hernandez Perez, MD         
Sponsors and Collaborators
Universidad Nacional Autonoma de Mexico
Hospital General de Mexico
Investigators
Layout table for investigator information
Principal Investigator: Rosa M Wong-Chew, MD, DSc Facultad de Medicina, Universidad Nacional Autonoma de Mexico

Layout table for additonal information
Responsible Party: Rosa Maria Wong Chew, Professor B. Head of the Infectious Diseases Research Laboratory, Universidad Nacional Autonoma de Mexico
ClinicalTrials.gov Identifier: NCT03683927     History of Changes
Other Study ID Numbers: CONACYT PN 2015-01-878
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rosa Maria Wong Chew, Universidad Nacional Autonoma de Mexico:
Respiratory infections
Probiotics
Microbiome
Viruses
Children

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases