Status:
TERMINATED
Efficacy and Safety of L. Plantarum and P. Acidilactici in Children With Upper Respiratory Tract Infections
Lead Sponsor:
AB Biotics, SA
Collaborating Sponsors:
Innovacion y Desarrollo de Estrategias en Salud
Hospital General Dr. Manuel Gea González
Conditions:
Upper Respiratory Tract Infections
Pharyngitis
Eligibility:
All Genders
6-5 years
Phase:
NA
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 wi...
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, take...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05279534
Start Date
March 8 2022
End Date
June 2 2023
Last Update
October 17 2023
Active Locations (1)
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1
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Mexico DF, Mexico, 14080