An interventional study of Probiotic and Placebo in Pharyngitis and Tonsillitis, sponsored by Innovacion y Desarrollo de Estrategias en Salud. Completed at 1 site in Mexico. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2019-06-20.
Sponsored by Innovacion y Desarrollo de Estrategias en Salud · Not applicable, Interventional, and Treatment
RCT in children (6m to 5y) with pharyngitis and/or tonsillitis who will be allocated to receive for 10 days L. reuteri DSM 17938 + L. reuteri ATCC PTA 5289) at a dose of 2x10\^8 Colony Forming Units (CFU). Five drops are to be taken twice a day (in the morning and in the evening) or placebo drops, as treatment for clinical condition. Duration of symptoms and reduction of pain (odynophagia) severity during treatment will be measured as primary outcome
Rationale. Acute respiratory infections (ARIs) are a common problem in the first decade of life. The yearly prevalence of respiratory tract infections in an otherwise healthy 3-year old child is about three to 10 infections. Children between 6 months and 5 years are more prone to develop pharyngitis and tonsillitis compared to older children. 60-70% of children with F/T lies within this age group. Aetiology the pharyngitis and tonsillitis is viral in 70% of all cases In developing countries 6/10 cases are treated using antibiotics, regardless of clinical guidelines or standard of care documents recommending only to use symptomatic drugs (NSAID).
Primary outcome. Duration of symptoms and reduction of pain (odynophagia) severity Secondary outcomes. Days with fever secondary to RTIs; Number of children receiving antibiotic treatment in each treatment group; Days of medical office visits or emergency visits; Total amount of medical office visits or emergency visits during the study, secondary to episodes of RTI; Days of absences from day care centre; Direct and Indirect costs Total costs of treatments including visit to private office, visit to emergency department, cost of treatment (NSAIDs + Probiotics vs NSAIDs + Placebo); Frequency of adverse events; Viral/bacterial load (multiplex-PCR); IgA in saliva and Change in salivary inflammatory biomarkers.
Interventions. L. reuteri DSM 17938 + L. reuteri ATCC PTA 5289) will be given at a dose of 2x10\^8 Colony Forming Units (CFU). Five drops are to be taken twice a day (in the morning and in the evening) giving a daily dose of 4x108 CFU/day. The placebo drops will have identical ingredients except for lacking the bacteria. Five drops are to be taken twice a day (in the morning and in the evening).
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's enrollment of 70 is below the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →Innovacion y Desarrollo de Estrategias en Salud is the lead sponsor of 9 studies on the registry; none are open to participants now.
Compared within Tonsillitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pharyngitis. 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.
L. reuteri ATCC PTA 5289 + L. reuteri DSM 17938 at a dose of 2x10\^8 Colony Forming Units (CFU)
Dietary Supplement: Probiotic
Five drops of Placebo taken twice a day (in the morning and in the evening).
Other: Placebo
L. reuteri Prodentis oil drops (L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289) will be given at a dose of 2x108 Colony Forming Units (CFU). Five drops are to be taken twice a day (in the morning and in the evening) giving a daily dose of 4x108 CFU/day.
Five drops of Placebo taken twice a day (in the morning and in the evening).
Clinical Improvement
Duration of respiratory symptoms
Time frame: 10 days
Fever improvement
Total number of hours during the study that the child is with temperature \>37.5oC measured twice a day since the moment they start to use the interventions and until the last visit into the study
Time frame: 10 days
Use of antibiotics
Total amount of days of antibiotic use during the study, secondary to the presence of episodes of RTI, reported since the beginning of the study products administration until the last visit occur
Time frame: 10 days
Medical/Emergency visits
Total amount of medical office visits or emergency visits during the study, secondary to episodes of RTI, reported since the beginning of the study products administration until the last visit occurs
Time frame: 10 days
Abseentisim
Total amount of days of absences from the day care centre during the study, secondary to the presence of episodes of RTI, reported since the beginning of the study products administration until the last visit occurs.
Time frame: 10 days
Costs of intervention
Total costs of treatments including visit to private office, visit to emergency department, cost of treatment (NSAIDs + Probiotics vs NSAIDs + Placebo)
Time frame: 10 days
Adverse events
Total number of adverse events which be reported by parents starting after randomization and finishing at the moment of last visit
Time frame: 10 days
Inflammatory improvements
Changes in IgA in saliva
Time frame: 10 days
Plan to share: No
Ran from Dec 2017 to primary completion in May 2018, 5 months.
Of 29 non-industry interventional studies with no phase under Tonsillitis, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 49. This study's 5 months is below that.
Counting every sponsor, half of 29 studies reached it within 20 months; a quarter within 10 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic
Innovacion y Desarrollo de Estrategias en Salud