NCT03516409

Bio-Kult Infantis® in AAD Prevention in Infants

Status unknown NA Last updated 12 September 2018

What this trial tests

NA trial testing Biokult in Acute Otitis Media in 276 participants. Status unknown.

Timeline

18 April 2018

Primary endpoint
15 December 2018

15 December 2018

Quick facts

Lead sponsor	Probiotics International Ltd.
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	276
Start date	18 April 2018
Primary completion	15 December 2018
Estimated completion	15 December 2018
Sites	1 location across Italy

Drugs / interventions tested

• Biokult
• Placebo

Conditions studied

• Acute Otitis Media — all drugs for Acute Otitis Media →

Sponsor

Probiotics International Ltd.

Who can join

Adults 6 Months to 35 Months, any sex, with Acute Otitis Media. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Probiotics for preventing acute otitis media in children.
   Scott AM, Clark J, Julien B, Islam F, et al · · 2019 · cited 20× · PMID 31210358 · DOI 10.1002/14651858.cd012941.pub2