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).

Condition	Treatment or Intervention	Phase
Otitis Media	Procedure: Craniosacral Osteopathic Manipulative Treatment  Drug: Botanicals	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  12 Months   -   60 Months,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Written informed consent

Arizona
      University of Arizona, Tucson,  Arizona,  85724-5073,  United States

Study chairs or principal investigators

Michael Aldous,  Principal Investigator,  University of Arizona   

Study ID Numbers:  1 P50 AT00008-01P1; 1 P50 AT00008-01
Record last reviewed:  October 2004
Last Updated:  October 20, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010465
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08