Acute Otitis Media Clinical Trial
— PROMAROfficial title:
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic on Recurrent Acute Otitis Media (rAOM) in Children
NCT number | NCT03614117 |
Other study ID # | OTR/17.01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2, 2018 |
Est. completion date | July 6, 2020 |
Verified date | October 2020 |
Source | ProbiSearch SL |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus salivarius PS7 on Acute Otitis Media (AOM) in children with recurrent AOM history. The study duration will be 7 months, which includes a 6-month product administration and a 1-month follow-up period. Participants will be randomized assigned to one of the three study groups: the control group; a 3 months probiotic +3 months placebo consumption group and a 6 months probiotic consumption group. The efficacy of the probiotic strain to reduce the incidence of AOM episodes will be assessed by counting AOM episodes occurring in study participants, during the entire intervention and follow-up periods, by bilateral comparison of each of the treatment groups with the control group according to the following hypothesis: "The number of AOM episodes occurring in participants who take the probiotic is the same as that for the participants in the control group. λc = λe". Where λc is the mean incidence of AOM in the control group and λe is the mean incidence of AOM in the groups taking the probiotic strain Lactobacillus salivarius PS7 obtained with 95% confidence interval.
Status | Completed |
Enrollment | 222 |
Est. completion date | July 6, 2020 |
Est. primary completion date | July 6, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 4 Years |
Eligibility | Inclusion Criteria: - Children 1 to 4 years of age with rAOM (3 episodes of AOM in the last 6 months, or 4 in the last 12 months). - Written informed consent signed by one of parents or legal guardian with the express or tacit consent of the other. - Presence of an AOM episode at the time of inclusion in the study. Exclusion Criteria: - chronic conditions under regular medication, such as asthma, allergic rhinitis… - congenital or acquired immunodeficiency, - taking systemic corticoid in the last 3 months for longer than 1 month - under present prophylactic antibiotic treatment - Down syndrome, - cleft lip or palate, - chronic tympanic perforation, - craniofacial abnormalities, - sleep apnea syndrome, - planned tympanostomy or tonsillectomy during the months of the study, - short bowel syndrome or any surgery in the gastrointestinal tract, - intestinal epithelial barrier defect (e.g., chronic diarrhea, intestinal inflammation), - metabolic disorders (diabetes, etc.), - heart failure and cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever or cardiac malformation), - uncertainty of the investigator regarding the willingness or capacity of the parents or legal guardian of the child to comply with the requirements of the protocol. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario QuirónSalud Pozuelo | Pozuelo De Alarcón | Madrid |
Lead Sponsor | Collaborator |
---|---|
ProbiSearch SL | Casen Recordati S.L. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Variables assessing compliance with the protocol | The variables assessing compliance with the protocol
Study product administration. Probiotic supplement administration Compliance with the visit/assessment intervals. |
7 months | |
Primary | Number of AOM episodes | Number of AOM episodes suffered by participants | 7 months | |
Secondary | Patients (%) with at least one AOM episode during the intervention and follow-up periods. | % of patients with at least one AOM episode | 7 months | |
Secondary | Number of AOM episodes after 3 months of product intake. | Number of AOM episodes suffered by participants after 3 months of product intake | 3 months | |
Secondary | Time from onset of first AOM episode to the onset of the next episode. | Number of days from onset of first AOM episode to the onset of the next episode. | 7 months | |
Secondary | Adverse events and/or serious adverse events | The number, duration and possible relationship of (serious) adverse events to the study product. | 7 months |
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