Acute Otitis Media Clinical Trial
Official title:
Efficacy of a Synbiotic Product (Probiotics + Prebiotics) in the Prevention of Antibiotics-associated Diarrhoea (AAD) in Infants. A Multicenter, Double Blind, Parallel Group, Placebo Controlled, Randomized Study
Background: antibiotic-associated diarrhoea (AAD) is defined as an acute inflammation of the
intestinal mucosa associated to the administration of antibiotics. Its aetiology seems to be
linked to the impact of antibiotics on the normal digestive microbiota. Acute otitis media
(AOM) is a common paediatric condition and it is one of the most commonly cited indication
for antimicrobial therapy in children (amoxicillin + clavulanic acid).
Treatment modalities for AAD are limited because no established treatment exists for
non-Clostridium difficile associated AAD, except for discontinuing antibiotic therapy.
Measures to prevent AAD include the use of probiotics. The rationale for the use of
probiotics in AAD assumes that, considering the pathogenesis of AAD, AAD is associated with
disturbance in the normal intestinal microbiota; administrating specific probiotic strains it
is possible to normalize unbalanced indigenous microbiota.
Scientific evidence suggests that prebiotics could be beneficial too. Prebiotics can act in
synergy with probiotics, being efficacious in suppressing the growth of pathogenic bacteria
that may occur during antibiotic therapy.
Study rationale: the principal side effects of treatment with amoxicillin-clavulanate include
diarrhoea, vomiting and allergic reactions. Aim of this study is to evaluate the
effectiveness of the administration of a synbiotic product, Bio-Kult Infantis®, in the
prevention of AAD during a standard therapy with amoxicillin-clavulanate to treat AOM.
Objective: to evaluate the effectiveness of a synbiotic product in the prevention of
Antibiotics-Associated Diarrhoea (AAD) during a concomitant standard therapy with amoxicillin
/ clavulanic acid, also known as co-amoxiclav, to treat Acute Otitis Media (AOM).
Study design: this is a multicenter, double blind, parallel group, placebo controlled,
randomized clinical study. 276 children 6 - 35 months old will be enrolled and then
randomized into one of the two study groups (Bio-Kult Infantis® + co-amoxiclav standard
treatment for AOM / placebo + co-amoxiclav standard treatment for AOM). A comparison will be
performed to evaluate the effectiveness of a synbiotic product in the prevention of AAD
during the concomitant standard therapy with co-amoxiclav.
During the study 4 visits will have to be performed at the study centre, and extra visits
will be performed in case of AOM relapse after recovery. The study will last for each patient
38 ± 6 days.
n/a
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