Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children

Phase 2

Completed

• Conditions: Otitis Media

• Registration Number: NCT00010465
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Brief 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).

Detailed 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 Timeline

• Study First Submitted: 2001-02-02
• Study First Submitted QC: 2001-02-02
• Study First Posted: 2001-02-05
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-21
• Last Update Posted: 2013-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Written informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States