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Otitis Media clinical trials

View clinical trials related to Otitis Media.

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NCT ID: NCT03655665 Recruiting - Otitis Media Clinical Trials

Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present

Start date: May 16, 2019
Phase: Phase 4
Study type: Interventional

To determine whether the use of topical otic drops intra-operative and post-operative during tympanostomy tube placement reduces the rate of tympanostomy tube occlusion and post-operative otorrhea (ear drainage) during the initial 4-week post-operative period in subjects with no middle ear effusion (fluid behind the ear drum) present at the time of surgery. A within subject controlled study design will be utilized to study this effect. Subjects with absent middle ear effusion who are receiving tympanostomy tube placement will receive a standard protocol of Floxin topical drops during surgery and after surgery in one ear. Selection of ear (right ear or left ear) will be randomized. The primary measured outcome will be the rate of tympanostomy tube occlusion within first 4 weeks postoperatively. The secondary measured outcome is the rate of tympanostomy tube otorrhea (drainage) within first 4 weeks postoperatively.

NCT ID: NCT03614117 Completed - Acute Otitis Media Clinical Trials

Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR)

PROMAR
Start date: October 2, 2018
Phase: N/A
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.

NCT ID: NCT03611842 Completed - Clinical trials for Otitis Media With Effusion

Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum

MMP and OME
Start date: September 30, 2018
Phase:
Study type: Observational

Metalloproteinases (MMPs) constitute a family of endopeptidases that cleaves the extracellular matrix as collagen included in the eardrum. Activity of MMP has been shown in some otitis media with effusion (OME) fluids. These enzymes could be directly linked to the prosnostic of OME as it may damage the eardrum and leads to tympanic atrophy. The main goal of the study is to find out the correlation between activity of MMPs and tympanic atrophy. The investigator will also study if there is any clinical predictive factors in relation to the level of MMPs.

NCT ID: NCT03603626 Withdrawn - Clinical trials for Post-operative Analgesia

Preemptive Pregabalin in Myringoplasty

Start date: September 2015
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the effect of preemptive pregabalin on post-operative pain reduction after myringoplasty.

NCT ID: NCT03590912 Completed - Clinical trials for Otitis Media With Effusion

Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion

Start date: September 5, 2018
Phase: Phase 4
Study type: Interventional

We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.

NCT ID: NCT03556215 Completed - Clinical trials for Chronic Recurrent Otitis Media

Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction

Start date: May 1, 2016
Phase: N/A
Study type: Interventional

The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group. Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. Subgroups will be compared in order to identify treatment effect in particular subgroups.

NCT ID: NCT03544138 Completed - Otitis Media Clinical Trials

In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old

Start date: July 24, 2018
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and performance of the Hummingbird® for the placement of ear tubes in children undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.

NCT ID: NCT03534219 Withdrawn - Acute Otitis Media Clinical Trials

Efficacy of the EarPopper Device in Children With Recurrent Otitis Media

Start date: July 24, 2018
Phase: N/A
Study type: Interventional

This is a randomized controlled clinical trial evaluating the efficacy of the EarPopper device (EP) in the reduction of episodes of acute otitis media (AOM) in children with recurrent otitis media. The control arm will be observational. The intervention arm will have the EP used.

NCT ID: NCT03516409 Recruiting - Acute Otitis Media Clinical Trials

Bio-Kult Infantis® in AAD Prevention in Infants

Start date: April 18, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03503591 Completed - Otitis Media Clinical Trials

Study of the Hummingbird TTS™ Tympanostomy Tube System

Start date: January 29, 2016
Phase:
Study type: Observational

The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.