An interventional study of Probiotic and Placebo in Upper Respiratory Tract Infections, Pharyngitis and Tonsillitis, sponsored by AB Biotics, SA. Terminated at 1 site in Mexico. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2023-10-17.
Sponsored by AB Biotics, SA (part of Kaneka Corporation) · Not applicable, Interventional, and Other
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.
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's enrollment of 80 is below the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →AB Biotics, SA is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
First submitted after AB Biotics, SA became part of Kaneka Corporation.
Compared within Tonsillitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Respiratory Tract Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Dietary Supplement: Probiotic
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.
Other: Placebo
Combination of strains Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485, and Pediococcus acidilactici CECT7483, twice daily for 15 days
Combination of maltodextrin (E1400, qs) in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0, twice daily for 15 days
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
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
Time frame: Day 1 to 60
Days with nasal congestion
Days of nasal congestion, as noted in patient diary
Time frame: Day 1 to 60
Days with any symptom
Days with one or more of the following symptom: fever, pain, rhinorrhea, cough or nasal congestion (as noted in patient diary)
Time frame: Day 1 to 60
Days with concomitant medication
Days of intake of NSAIDS (non-steroidal anti-inflammatory drugs) and/or antihistamines, as noted in patient diary
Time frame: Day 1 to 60
Number of children receiving antibiotics
Number of children receiving antibiotics
Time frame: Day 1 to 60
Number of hospitalizations
Number of children being hospitalized related to respiratory tract infection
Time frame: Day 1 to 60
Number of medical or emergency visits
Number of medical or emergency visits related to respiratory tract infection
Time frame: Day 1 to 60
Days of schooling absence
Days of daycare or kindergarten absence, as noted in patient diary
Time frame: Day 1 to 60
Change in salivary immune biomarkers
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
Time frame: Day 1 to 15
Total treatment costs
Cost of medical and emergency visits, drug treatments (anti-inflammatory drugs, anti-histamines and antibiotics) and schooling absence
Time frame: Day 1 to 60
Time to fever resolution
Time to body temperature at or below 37.5 Celsius, as noted in patient diary
Time frame: Day 1 to 15
Time to pain resolution
Time to FLACC (Face, Legs, Activity, Cry and Consolability, ranging 0 \[no pain\] to 10 \[maximum pain\]) score \< 2, as noted in patient diary
Time frame: Day 1 to 15
Time to complete symptom resolution
Time to clearance of all of the following symptoms: fever, pain, rhinorrhea, cough and nasal congestion, as noted in patient diary
Time frame: Day 1 to 15
Time to fever recurrence
Time to body temperature \>37.5 Celsius after initial resolution (see outcome #19), as noted in patient diary
Time frame: Day 15 to 60
Time to pain recurrence
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
Time frame: Day 15 to 60
Time to any symptom recurrence
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
Time frame: Day 15 to 60
Change in microbiota
Change in microbiota composition, as determined by 16S gene sequencing
Time frame: Day 1 to 15
Etiology of the upper respiratory tract infection at baseline
Identification of the viral or bacterial pathogen responsible for the baseline episode of upper respiratory tract infection by molecular methods
Time frame: Day 1
Salivary vitamin D at baseline
Concentration of vitamin D at baseline as measured in saliva sample
Time frame: Day 1
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic