Efficacy and Safety of L. Plantarum and P. Acidilactici in Children With Upper Respiratory Tract Infections
- Conditions
- PharyngitisUpper Respiratory Tract InfectionsTonsillitis
- Interventions
- Other: PlaceboDietary Supplement: Probiotic
- Registration Number
- NCT05279534
- Lead Sponsor
- AB Biotics, SA
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Placebo 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. Probiotic Probiotic 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
- Primary Outcome Measures
Name Time Method Daily evolution of fever Day 1 to 15 Daily severity of fever (Celsius degrees), as measured with an infrared thermometer (same model for all recruited subjects) and noted in patient diary
Daily evolution of pain Day 1 to 15 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
- Secondary Outcome Measures
Name Time Method Change in microbiota Day 1 to 15 Change in microbiota composition, as determined by 16S gene sequencing
Time to complete symptom resolution Day 1 to 15 Time to clearance of all of the following symptoms: fever, pain, rhinorrhea, cough and nasal congestion, as noted in patient diary
Time to fever recurrence Day 15 to 60 Time to body temperature \>37.5 Celsius after initial resolution (see outcome #19), as noted in patient diary
Time to pain recurrence Day 15 to 60 Time to FLACC (Face, Legs, Activity, Cry and Consolability, ranging 0 \[no pain\] to 10 \[maximum pain\]) score \> 3 after initial resolution (see outcome #20), as noted in patient diary
Days with cough Day 1 to 60 Days of cough, as noted in patient diary
Change in salivary immune biomarkers Day 1 to 15 Change in concentration of Immunoglobulin A (IgA), Tumor Necrosis Factor-alpha (TNFa), Interleukin 1-beta (IL-1b) and Interleukin 10 (IL-10) in saliva samples
Days with nasal congestion Day 1 to 60 Days of nasal congestion, as noted in patient diary
Number of hospitalizations Day 1 to 60 Number of children being hospitalized related to respiratory tract infection
Number of medical or emergency visits Day 1 to 60 Number of medical or emergency visits related to respiratory tract infection
Time to fever resolution Day 1 to 15 Time to body temperature at or below 37.5 Celsius, as noted in patient diary
Time to any symptom recurrence Day 15 to 60 Time to recurrence of any symptom (fever, pain, rhinorrhea, cough and nasal congestion) after initial complete symptom resolution (see outcome #21), as noted in patient diary
Total treatment costs Day 1 to 60 Cost of medical and emergency visits, drug treatments (anti-inflammatory drugs, anti-histamines and antibiotics) and schooling absence
Fever Area Under the Curve Day 1 to 60 Area Under the Curve (AUC) of daily fever (body temperature, Celsius degrees)
Pain Area Under the Curve Day 1 to 60 Area Under the Curve (AUC) of daily pain, as per FLACC scale (Face, Legs, Activity, Cry and Consolability, ranging 0 \[no pain\] to 10 \[maximum pain\])
Days with fever Day 1 to 60 Days with body temperature \> 37.5 Celsius, as noted in patient diary
Days with pain Day 1 to 60 Days with pain as per FLACC scale (Face, Legs, Activity, Cry and Consolability), as noted in patient diary
Days with rhinorrhea Day 1 to 60 Days with runny nose, as noted in patient diary
Days with any symptom Day 1 to 60 Days with one or more of the following symptom: fever, pain, rhinorrhea, cough or nasal congestion (as noted in patient diary)
Time to pain resolution Day 1 to 15 Time to FLACC (Face, Legs, Activity, Cry and Consolability, ranging 0 \[no pain\] to 10 \[maximum pain\]) score \< 2, as noted in patient diary
Days with concomitant medication Day 1 to 60 Days of intake of NSAIDS (non-steroidal anti-inflammatory drugs) and/or antihistamines, as noted in patient diary
Number of children receiving antibiotics Day 1 to 60 Number of children receiving antibiotics
Days of schooling absence Day 1 to 60 Days of daycare or kindergarten absence, as noted in patient diary
Trial Locations
- Locations (1)
Hospital General Dr. Manuel Gea Gonzalez
🇲🇽Mexico City, Mexico DF, Mexico