Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03516409
Study type Interventional
Source Probiotics International Ltd.
Contact Ashton Harper, Dr.
Phone +44 7712 321 033
Email Ashton.Harper@protexin.com
Status Recruiting
Phase N/A
Start date April 18, 2018
Completion date December 15, 2018

See also
  Status Clinical Trial Phase
Completed NCT02092454 - Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media Phase 2
Completed NCT01202578 - Evaluation of the Tympanostomy Tube Delivery System Phase 2/Phase 3
Withdrawn NCT00502450 - Is There Hearing Loss After Acute Mastoiditis N/A
Completed NCT04296448 - Evaluation of Cellphone Based Otoscopy in Pediatric Patients N/A
Terminated NCT05651633 - Analgesic Ear Drops for Children With Acute Otitis Media Phase 3
Completed NCT02345447 - Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence Phase 3
Completed NCT01941381 - Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?
Recruiting NCT01214538 - Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children N/A
Completed NCT03614117 - Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR) N/A
Recruiting NCT06027593 - Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions N/A
Completed NCT02918773 - Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto) N/A
Completed NCT02567747 - Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age
Completed NCT02935374 - Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children Phase 4
Completed NCT02567825 - Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media N/A
Completed NCT02037893 - Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media Phase 2
Completed NCT00578773 - A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea Phase 2
Completed NCT00377260 - Acute Otitis Media (AOM) Therapy Trial in Young Children Phase 4
Completed NCT00645112 - A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media Phase 4
Completed NCT00368823 - A Trial of Point of Care Information in Ambulatory Pediatrics Phase 3
Completed NCT01272999 - Impact of Prevnar 13 on Ear Infections in Children