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

NCT03683927 | Unknown Phase 1

• 1 other identifier: CONACYT PN 2015-01-878
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Infections in Children

Keywords

Respiratory infections; Probiotics; Microbiome; Viruses; Children

Outcome Measures

Primary Outcomes (1)

• Number of respiratory infections in the first year of life

  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

  1 year

Secondary Outcomes (2)

• Rates of bacterial phyla in nasal and intestinal washes

  1 year

• Number of viruses detected in nasal washes during the follow up

  1 year

Study Arms (2)

Probiotics

EXPERIMENTAL

Probiotics consist on Bacillus clausii in a plastic vial that will be administered to the infant 4 times a week

Combination Product: Bacillus clausii

Placebo group

PLACEBO COMPARATOR

Sterile water contained in a plastic vial will be administered to the infant 4 times a week

Other: Sterile water

Interventions

Bacillus clausii COMBINATION_PRODUCT

The probiotic (Bacillus clausii) will be administered 4 times a week to the infant

Probiotics

Sterile water OTHER

The placebo group will receive sterile water 4 times a week

Placebo group

Eligibility Criteria

• Age: 3 Hours - 2 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Preterm newborns
• Co-morbidities

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead
• Hospital General de Mexico: collaborator

Study Sites (1)

Rosa Maria Wong-Chew

Mexico City, 04510, Mexico

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections; Virus Diseases

Interventions

clausin peptide, Bacillus clausii

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Rosa M Wong-Chew, MD, DSc

  Facultad de Medicina, Universidad Nacional Autonoma de Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosa M Wong-Chew, MD, DSc

CONTACT

5255 56232300; rmwong@unam.mx

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor B. Head of the Infectious Diseases Research Laboratory

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 25, 2018
• Study Start: January 10, 2018
• Primary Completion: January 9, 2020
• Study Completion: March 10, 2020
• Last Updated: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)