Efficacy and Safety of L. Plantarum and P. Acidilactici in Children With Upper Respiratory Tract Infections
Upper Respiratory Tract Infections, Pharyngitis, Tonsillitis
About this trial
This is an interventional other trial for Upper Respiratory Tract Infections focused on measuring Probiotic
Eligibility Criteria
Inclusion Criteria:
- Male and female children, 6 months to 5 years-old
- Diagnosed with upper respiratory tract infection with pharyngitis and/or tonsillitis by a physician
- With fever >37.5 Celsius degrees and FLACC (Face, Legs, Activity, Cry and Consolability) score >3
- Symptom onset no more than 48h before study entry
- Body weight at birth >2500 gr
- Informed consent provided by parents or legal guardians
Exclusion Criteria:
- Failure to thrive
- Asthma or significant allergic disease
- Use of antibiotics, antivirals, probiotics or prebiotics for more than 48h within 2 weeks of study entry
- History of recurrent respiratory infections (>2 otitis, >1 severe sinusitis or >1 pneumonia) within 12 months of study entry
- History of 2 or more invasive infections (meningitis, cellulitis, osteomyelitis, sepsis)
- Chronic diarrhea or short bowel syndrome
- Congenital heart or respiratory deficiency
- Known alpha1-antitrypsin deficiency
- Concurrent participation in other clinical trial(s)
- Other particular conditions which, in the judgment of the Principal Investigator, may interfere with the study
Sites / Locations
- Hospital General Dr. Manuel Gea Gonzalez
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Probiotic
Control
Active test product contains four lactic acid bacteria strains with Qualified Presumption of Safety (QPS) status by European Food Safety Authority (EFSA): Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485, and Pediococcus acidilactici CECT7483, with maltodextrin (E1400, qs) as excipient, formulated in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0. Active test product is a food supplement and not an investigational medicinal product
The control study product is identical in packaging and formulation except that none of strains Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485 and Pediococcus acidilactici CECT7483 (probiotic bacteria) are present. The Control product contains maltodextrin (E1400, qs) only, in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0.