Antibiotic Side Effect
Conditions
Brief summary
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.
Detailed description
Objectives Several studies have demonstrated that probiotics can be helpful in preventing antibiotic-associated diarrhoea in hospitalized patients. However, the extent to which probiotics may benefit healthy adults taking a course of antibiotics has not been investigated in primary care. Furthermore, patient willingness to take a probiotic supplement concomitantly with antibiotics has not been explored. We aimed to conduct an exploratory study using probiotics in adults requiring an acute course of antibiotic therapy. Methods Patients prescribed antibiotics for treatment of acute infections in an outpatient family practice setting were randomized to receive either a probiotic or placebo concurrently. Patients completed adherence diaries and daily symptom checklists to assess gastrointestinal and vaginal (women) symptoms and collect information about adherence.
Interventions
DIETARY_SUPPLEMENTProbiotic
Probiotic capsule, 2 capsules twice daily
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of antibiotic associated diarrhea | two weeks after start of antibiotics | Groups will be compared based on rates of antibiotic associated diarrhea, symptoms developing in the two week window of when antibiotics are started. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant knowledge of probiotics | At participant recruitment | Assess current knowledge of probiotics of participants at the time of recruitment to study |
Countries
United States
Outcome results
None listed