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| Name | Class |
|---|---|
| Innovacion y Desarrollo de Estrategias en Salud | OTHER |
| Hospital General Dr. Manuel Gea González | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | 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 |
|
| Control | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Combination of strains Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485, and Pediococcus acidilactici CECT7483, twice daily for 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Day 1 to 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Fever Area Under the Curve | Area Under the Curve (AUC) of daily fever (body temperature, Celsius degrees) | 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]) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 |
| Salivary vitamin D at baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Gutierrez-Castrellon, MD, PhD | Hospital General Dr. Manuel Gea Gonzalez | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Dr. Manuel Gea Gonzalez | Mexico City | Mexico DF | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12723828 | Background | Manworren RC, Hynan LS. Clinical validation of FLACC: preverbal patient pain scale. Pediatr Nurs. 2003 Mar-Apr;29(2):140-6. | |
| 35014600 | Background | Gutierrez-Castrellon P, Gandara-Marti T, Abreu Y Abreu AT, Nieto-Rufino CD, Lopez-Orduna E, Jimenez-Escobar I, Jimenez-Gutierrez C, Lopez-Velazquez G, Espadaler-Mazo J. Probiotic improves symptomatic and viral clearance in Covid19 outpatients: a randomized, quadruple-blinded, placebo-controlled trial. Gut Microbes. 2022 Jan-Dec;14(1):2018899. doi: 10.1080/19490976.2021.2018899. |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D010612 | Pharyngitis |
| D014069 | Tonsillitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Randomized controlled trials. Study subjects (6 months to 5 years-old) will be allocated to receive a combination of strains Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485, and P. acidilactici CECT7483 (arm one) or placebo (arm two)
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All study staff, including the Principal Investigator and the persons performing the subject assessments, will be blinded during the study. Sealed individual treatment code envelopes will be kept at the clinic to be able to break the code if any emergency occurs, as judged by the Investigator
| Placebo | Other | Combination of maltodextrin (E1400, qs) in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0, twice daily for 15 days |
|
| Day 1 to 60 |
| Days with fever | Days with body temperature > 37.5 Celsius, as noted in patient diary | 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 | Day 1 to 60 |
| Days with rhinorrhea | Days with runny nose, as noted in patient diary | Day 1 to 60 |
| Days with cough | Days of cough, as noted in patient diary | Day 1 to 60 |
| Days with nasal congestion | Days of nasal congestion, as noted in patient diary | 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) | 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 | Day 1 to 60 |
| Number of children receiving antibiotics | Number of children receiving antibiotics | Day 1 to 60 |
| Number of hospitalizations | Number of children being hospitalized related to respiratory tract infection | Day 1 to 60 |
| Number of medical or emergency visits | Number of medical or emergency visits related to respiratory tract infection | Day 1 to 60 |
| Days of schooling absence | Days of daycare or kindergarten absence, as noted in patient diary | 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 | 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 | Day 1 to 60 |
| Time to fever resolution | Time to body temperature at or below 37.5 Celsius, as noted in patient diary | 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 | 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 | 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 | 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 | 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 | Day 15 to 60 |
| Change in microbiota | Change in microbiota composition, as determined by 16S gene sequencing | Day 1 to 15 |
Concentration of vitamin D at baseline as measured in saliva sample
| Day 1 |
| 33789556 | Background | Maya-Barrios A, Lira-Hernandez K, Jimenez-Escobar I, Hernandez L, Ortiz-Hernandez A, Jimenez-Gutierrez C, Lopez-Velazquez G, Gutierrez-Castrellon P. Limosilactobacillus reuteri ATCC PTA 5289 and DSM 17938 as adjuvants to improve evolution of pharyngitis/tonsillitis in children: randomised controlled trial. Benef Microbes. 2021 Apr 12;12(2):137-145. doi: 10.3920/BM2020.0171. Epub 2021 Apr 1. |
| 9220806 | Background | Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7. |
| D010038 |
| Otorhinolaryngologic Diseases |
| D019602 |
| Food and Beverages |