Upper Respiratory Tract InfectionsNCT05279534
Efficacy and Safety of L. Plantarum and P. Acidilactici in Children With Upper Respiratory Tract Infections
A study testing Probiotic in people with Upper Respiratory Tract Infections and Pharyngitis, run by AB Biotics, SA at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Upper Respiratory Tract Infections, Pharyngitis, Tonsillitis
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- 8 Mar 2022to 2 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Mexico DF, 14080
About this study
Official title: Efficacy and Safety of Lactobacillus Plantarum and Pediococcus Acidilactici as Twice-daily Co-adjuvant Therapy of Upper Respiratory Tract Infections in Children 6 Months to 5 Years Old
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.
Read the 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.
- Conditions
- Upper Respiratory Tract Infections, Pharyngitis, Tonsillitis
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotic
- Medical subject headings
- Respiratory Tract Infections, Pharyngitis, Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Probiotic |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 1 to 15
Secondary outcomes (22)
Fever Area Under the Curve
Area Under the Curve (AUC) of daily fever (body temperature, Celsius degrees)
Measured: 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])
Measured: Day 1 to 60
Days with fever
Days with body temperature > 37.5 Celsius, as noted in patient diary
Measured: 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
Measured: Day 1 to 60
Days with rhinorrhea
Days with runny nose, as noted in patient diary
Measured: Day 1 to 60
Days with cough
Days of cough, as noted in patient diary
Measured: Day 1 to 60
Days with nasal congestion
Days of nasal congestion, as noted in patient diary
Measured: 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)
Measured: 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
Measured: Day 1 to 60
Number of children receiving antibiotics
Number of children receiving antibiotics
Measured: Day 1 to 60
Number of hospitalizations
Number of children being hospitalized related to respiratory tract infection
Measured: Day 1 to 60
Number of medical or emergency visits
Number of medical or emergency visits related to respiratory tract infection
Measured: Day 1 to 60
Days of schooling absence
Days of daycare or kindergarten absence, as noted in patient diary
Measured: 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
Measured: 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
Measured: Day 1 to 60
Time to fever resolution
Time to body temperature at or below 37.5 Celsius, as noted in patient diary
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 15 to 60
Change in microbiota
Change in microbiota composition, as determined by 16S gene sequencing
Measured: Day 1 to 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start8 Mar 2022
- Primary completion2 Jun 2023
- Study completion2 Jun 2023
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovacion y Desarrollo de Estrategias en Salud, Hospital General Dr. Manuel Gea González
- Responsible party
- Sponsor
- Investigators
- Pedro Gutierrez-Castrellon, MD, PhD, Principal investigator, Hospital General Dr. Manuel Gea Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279534
- Sponsor's protocol ID
- PROPED-URTI
- Status last verified
- Oct 2023
- First submitted
- 7 Mar 2022
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manworren RC, Hynan LS. Clinical validation of FLACC: preverbal patient pain scale. Pediatr Nurs. 2003 Mar-Apr;29(2):140-6.
PubMed 12723828Gutierrez-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.
PubMed 35014600Maya-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.
PubMed 33789556Merkel 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.
PubMed 9220806
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lactobacillus Plantarum and Pediococcus Acidilactici as Twice-daily Co-adjuvant Therapy of Upper Respiratory Tract Infections in Children 6 Months to 5 Years Old
- ClinicalTrials.gov ID
- NCT05279534
- Acronym / sponsor ID
- PROPED-URTI
- Conditions
- Upper Respiratory Tract Infections, Pharyngitis, Tonsillitis
- Keywords
- Probiotic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 80 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Collaborators
- Innovacion y Desarrollo de Estrategias en Salud, Hospital General Dr. Manuel Gea González
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticActive 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 | Other: PlaceboThe 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. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticCombination of strains Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485, and Pediococcus acidilactici CECT7483, twice daily for 15 days | Dietary supplement | Probiotic |
| PlaceboCombination of maltodextrin (E1400, qs) in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0, twice daily for 15 days | Other | Control |
Primary outcome
Daily evolution of fever
Time frame: 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
Time frame: 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
22 secondary outcomes
Fever Area Under the Curve
Time frame: Day 1 to 60
Pain Area Under the Curve
Time frame: Day 1 to 60
Days with fever
Time frame: Day 1 to 60
Days with pain
Time frame: Day 1 to 60
Days with rhinorrhea
Time frame: Day 1 to 60
Days with cough
Time frame: Day 1 to 60
Days with nasal congestion
Time frame: Day 1 to 60
Days with any symptom
Time frame: Day 1 to 60
Days with concomitant medication
Time frame: Day 1 to 60
Number of children receiving antibiotics
Time frame: Day 1 to 60
Number of hospitalizations
Time frame: Day 1 to 60
Number of medical or emergency visits
Time frame: Day 1 to 60
Days of schooling absence
Time frame: Day 1 to 60
Change in salivary immune biomarkers
Time frame: Day 1 to 15
Total treatment costs
Time frame: Day 1 to 60
Time to fever resolution
Time frame: Day 1 to 15
Time to pain resolution
Time frame: Day 1 to 15
Time to complete symptom resolution
Time frame: Day 1 to 15
Time to fever recurrence
Time frame: Day 15 to 60
Time to pain recurrence
Time frame: Day 15 to 60
Time to any symptom recurrence
Time frame: Day 15 to 60
Change in microbiota
Time frame: Day 1 to 15
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 12723828Manworren RC, Hynan LS. Clinical validation of FLACC: preverbal patient pain scale. Pediatr Nurs. 2003 Mar-Apr;29(2):140-6.
- Background: PubMed 35014600Gutierrez-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.
- Background: PubMed 33789556Maya-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.
- Background: PubMed 9220806Merkel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Gutierrez-Castrellon, MD, PhD principal investigator
Hospital General Dr. Manuel Gea Gonzalez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Upper Respiratory Tract Infections and Pharyngitis, run by AB Biotics, SA at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily evolution of fever (time frame: Day 1 to 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05279534, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.