Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR)
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      The parent or legal guardian of the minors will be contacted during a visit to the
      pediatrician for suspected AOM to request their participation in the study, which will be
      voluntary.

      The study visits will take place at the primary care center or hospital. During Visit 1, the
      inclusion and exclusion criteria will be verified, and the informed consent will be signed.
      Information will be collected on the demographic profile, characteristics of the AOM episode
      and the prescribed treatment; and the participants will be randomized. The investigator will
      give the parent or guardian the product corresponding to the first treatment period (3
      months) and will explain how to administer it to the child, as well as when the next visits
      will take place and what they will entail. Instructions will be given to start the
      administration of the product as soon as possible after the collection of the first stool
      sample. A sample will be collected from the outer ear most affected by the AOM using a
      sterile swab (Day 0). The investigator will go over, with the parent or legal guardian, the
      details of the diary to be completed (Annex II), how to record the data on product
      administration, fever episodes, days of school or daycare missed, unscheduled visits to the
      pediatrician, as well as data related to the frequency and characteristics of the stools in
      the event of AOM episodes and/or antibiotic treatment. The investigator will inform the
      parent or legal guardian that, during the child's participation in the study, the child
      cannot take any probiotic supplement.

      During Visit 2, a sample will be taken from the same ear as in the previous visit using a
      sterile swab. Any questions regarding completing the diary will be discussed. The leftover
      product from the first treatment period will be collected and the study product corresponding
      to the second supplement administration period will be dispensed.

      At the third visit (Visit 3, after 6 months of product administration), a sample will be
      collected from the same ear as in previous visits using a sterile swab. Any leftover product
      from the second treatment period will be collected.

      During the fourth visit (Visit 4, after 1 month of observation), a sample will be collected
      from the same ear as in previous visits using a sterile swab. The completed diary will be
      collected.

      Throughout the duration of the child's participation in the study (7 months), additional
      visits to the pediatrician (study investigator) may take place. If an episode of AOM, otitis
      externa or respiratory tract infection occurs during the intervention period, the
      investigator will make a diagnosis and will start the necessary treatment. In the course of
      new AOM episodes, during the intervention period, the administration of the product will not
      be interrupted. If the AOM episode occurs during the observation period, the investigator
      will proceed according to his/her routine practice. At the additional visits taking place,
      relevant data will be collected on the possible Adverse Events (AEs) or Serious Adverse
      Events (SAEs), as well as on the concomitant medication.
    

Intervention name(s): Lactobacillus salivarius PS7 during 6 months; Lactobacillus salivarius PS7 during 3 months; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 7 months intervention study: A 6 months intervention period and 1 month follow-up after intervention finishing time. During the 6 months of intervention the participants will intake one daily dose of the product that contains 1*10E9 CFU of L. salivarius PS7. Then, a 1 month follow-up period will be completed.; 7 months intervention study: A 6 months intervention period and 1 month follow-up after intervention finishing time. During the 3 months of intervention the participants will intake one daily dose of the product that contains 1*10E9 CFU of L. salivarius PS7. After that, the participants will intake one daily dose of the placebo. Then, a 1 month follow-up period will be completed.; 7 months intervention study: A 6 months intervention period and 1 month follow-up after intervention finishing time. During the 6 months of intervention the participants will intake one daily dose of placebo supplement.Then, a 1 month follow-up period will be completed.
Other intervention name(s): Lactobacillus salivarius CECT9422 during 6 months; Lactobacillus salivarius CECT9422 during 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is an interventional, randomized, double-blind, placebo-controlled, parallel-group study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention