NCT03683927

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

Status unknown Phase 1 Last updated 27 September 2018

What this trial tests

Phase 1 trial testing Bacillus clausii in Respiratory Infections in Children in 120 participants. Status unknown.

Timeline

10 January 2018

Primary endpoint
9 January 2020

10 March 2020

Quick facts

Lead sponsor	Universidad Nacional Autonoma de Mexico
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	120
Start date	10 January 2018
Primary completion	9 January 2020
Estimated completion	10 March 2020
Sites	1 location across Mexico

Drugs / interventions tested

• Bacillus clausii — full drug profile →
• Sterile water (Sterile Water For Injection) — full drug profile →

Conditions studied

• Respiratory Infections in Children — all drugs for Respiratory Infections in Children →

Sponsor

Universidad Nacional Autonoma de Mexico — full company profile →

Who can join

Adults 3 Hours to 2 Days, any sex, with Respiratory Infections in Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Targeted Delivery of Probiotics: Perspectives on Research and Commercialization.
   Yoha KS, Nida S, Dutta S, Moses JA, et al · · 2022 · cited 54× · PMID 33904011 · DOI 10.1007/s12602-021-09791-7