Efficacy and Safety of L. Plantarum and P. Acidilactici in Children With Upper Respiratory Tract Infections

AB Biotics

Status: Terminated

Conditions: Upper Respiratory Tract Infections; Tonsillitis; Pharyngitis

Treatments: Other: Placebo; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05279534

PROPED-URTI

Details and patient eligibility

About

Randomized, placebo-controlled trial to evaluate the coadjuvant effect of a combination of L. plantarum and P. acidilactici probiotic strains, taken twice daily, in children 6 months to 5 years-old with upper respiratory tract infections with pharyngitis and/or tonsillitis. Main objective is to evaluate efficacy of this probiotic in reducing fever and pain, as well to evaluate its safety.

Full description

Randomized, placebo-controlled trial (RCT) to evaluate the coadjuvant effect of probiotic strains L. plantarum CECT30292, L.plantarum CECT7484 and CECT7485 together with P. acidilactici CECT7483, taken twice daily, in children 6 months to 5 years-old with upper respiratory tract infections with pharyngitis and/or tonsillitis, as diagnosed by a physician.

Main objective is to evaluate efficacy of this probiotic in reducing fever (as per infrared thermometer, same model for all recruited subjects) and pain (as per FLACC scale [Face, Legs, Activity, Cry and Consolability]), as well to evaluate its safety. Secondary objectives include effect on cough, rhinorrhea, nasal congestion, use of concomitant medication, emergency visits, hospitalizations, schooling absences and salivary immune markers.

Probiotic intervention will last 15 days, and patients will return for follow-up visits on the last day of probiotic intervention (day 15), and well as day 30 and 60.

The study aims at enrolling and randomizing 80 children fulfilling entry criteria and living in Mexico City area (2,200m over the sea level), after parents or legal guardians sign informed consent.

Enrollment: 80 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic

Control

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo