Antibiotic Side Effect Clinical Trial
Official title:
Feasibility Study of Probiotics in Primary Care
Antibiotics are lifesaving medicines and generally safe, yet unwanted side effects are common. While destroying illness-causing 'bad' bacteria, antibiotics can upset the protective 'good' bacteria in the body. This research will test if taking a probiotic with prescribed antibiotics will decrease the chance of having bothersome antibiotic-associated side effects.
Status | Completed |
Enrollment | 51 |
Est. completion date | April 2014 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 79 Years |
Eligibility |
Inclusion Criteria: - adults 18 - 79 years of age with infection requiring an oral antibiotic. - Must be able to be contacted via telephone. Exclusion criteria: - pregnancy, - breast-feeding, - those receiving tube feeding, - those with diarrhea as a current symptom of present illness, and pre-existing illnesses that contribute to diarrhea such as inflammatory bowel disease, - irritable bowel syndrome, colitis or celiac disease. - Those undergoing active cancer treatments with chemotherapeutic or radiation therapy, - immunocompromised persons, - history of cardiac valvular disease, - those taking a laxative or stool softener on a daily basis, as well as - persons treated with an antibiotic in the previous 60 days, - new antibiotic prescription that exceeds a 10 day course, or regular use of a probiotic within the previous three weeks (including daily ingestion of yogurt). |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | M.S. Hershey Medical Center, Dept of Family and Community Medicine | Hershey, | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of antibiotic associated diarrhea | Groups will be compared based on rates of antibiotic associated diarrhea, symptoms developing in the two week window of when antibiotics are started. | two weeks after start of antibiotics | No |
Secondary | Participant knowledge of probiotics | Assess current knowledge of probiotics of participants at the time of recruitment to study | At participant recruitment | No |
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