Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine the efficacy of echinacea therapy and osteopathic manipulation for the prevention of further ear infections in children with recurrent ear infections (otitis media).


Clinical Trial Description

Acute otitis media (inflammation of the middle ear) occurs in 60% of infants during the first year of life and in 85% by age 3. Approximately 17% of children suffer recurrent otitis media during the first year of life. Following acute otitis media, middle ear fluid effusions can persist for weeks to months. Approximately 40% of children with middle ear effusions have mild to moderate hearing loss for the duration of the effusion, and several studies have found evidence for impaired speech and language development among children with prolonged middle ear effusion. Since antibiotic use has become widespread, concern has emerged regarding antibiotic resistant S. pneumoniae strains and other bacteria. Children with recurrent otitis media commonly receive prophylactic antibiotic therapy or surgical insertion of tubes to prevent accumulation of middle ear effusion. The prevalence of pediatric use of complementary alternative medical (CAM) approaches for prevention of otitis media has not been widely quantified. This study will evaluate the use of osteopathic manipulation and echinacea therapy to prevent ear infection in children with recurrent otitis media. ;


Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00010465
Study type Interventional
Source National Center for Complementary and Integrative Health (NCCIH)
Contact
Status Completed
Phase Phase 2
Completion date December 2002

See also
  Status Clinical Trial Phase
Completed NCT04016051 - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections Phase 3
Completed NCT02452164 - Family MobilePhone Otoscopy in Diagnostics of Otitis Media N/A
Completed NCT01199016 - Effect of Prevnar 13 on Ear Infections in Children Phase 4
Terminated NCT00778063 - Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients N/A
Completed NCT00195611 - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media Phase 4
Recruiting NCT03722160 - Clinical Study of the Solo Tympanostomy Tube Device N/A
Recruiting NCT04447521 - Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium
Active, not recruiting NCT05127161 - Broad Implementation of Outpatient Stewardship N/A
Completed NCT02600559 - Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes Phase 3
Completed NCT01444391 - inVENT-visIOn Study N/A
Enrolling by invitation NCT01437436 - The Effect of Obesity on Ventilation Tube Insertion N/A
Completed NCT01003210 - Homeopathic Ear Drops for Otitis Media Study N/A
Completed NCT00768534 - Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media N/A
Recruiting NCT00393159 - The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children Phase 4
Completed NCT00617682 - Maternal Immunization To Prevent Infant Otitis Media Phase 1/Phase 2
Withdrawn NCT00956748 - N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media Phase 4
Withdrawn NCT01908764 - Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery Phase 1
Recruiting NCT01619462 - Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children Phase 3
Completed NCT02616458 - The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population N/A
Completed NCT00051753 - Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media Phase 3