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

AB Biotics, SA80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Upper Respiratory Tract Infections Pharyngitis Tonsillitis

Interventions

ProbioticDIETARY_SUPPLEMENT

Combination of strains Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485, and Pediococcus acidilactici CECT7483, twice daily for 15 days

PlaceboOTHER

Combination of maltodextrin (E1400, qs) in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0, twice daily for 15 days

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital General Dr. Manuel Gea Gonzalez

Mexico City, Mexico DF, Mexico

Outcomes

Primary Outcomes

Daily evolution of fever

Daily severity of fever (Celsius degrees), as measured with an infrared thermometer (same model for all recruited subjects) and noted in patient diary

Time frame: Day 1 to 15

Daily evolution of pain

Daily severity of pain, as per FLACC scale (Face, Legs, Activity, Cry and Consolability, ranging 0 \[no pain\] to 10 \[maximum pain\]) and noted in patient diary

Time frame: Day 1 to 15

Secondary Outcomes

Fever Area Under the Curve

Area Under the Curve (AUC) of daily fever (body temperature, Celsius degrees)

Time frame: Day 1 to 60

Pain Area Under the Curve

Area Under the Curve (AUC) of daily pain, as per FLACC scale (Face, Legs, Activity, Cry and Consolability, ranging 0 \[no pain\] to 10 \[maximum pain\])

Time frame: Day 1 to 60

Days with fever

Days with body temperature \> 37.5 Celsius, as noted in patient diary

Time frame: Day 1 to 60

Days with pain

Days with pain as per FLACC scale (Face, Legs, Activity, Cry and Consolability), as noted in patient diary

Time frame: Day 1 to 60

Days with rhinorrhea

Days with runny nose, as noted in patient diary

Time frame: Day 1 to 60

Days with cough

Days of cough, as noted in patient diary

Data from ClinicalTrials.gov

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