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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Placebo Comparator | Participants are provided in double blinded fashion, probiotic given to take with antibiotics prescribed by their provider. |
|
| Placebo | Placebo Comparator | Participants are provided in double blinded fashion, Look alike placebo given to take with antibiotics prescribed by their provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Probiotic capsule, 2 capsules twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant knowledge of probiotics | Assess current knowledge of probiotics of participants at the time of recruitment to study | At participant recruitment |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William J Curry, MD, MS | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M.S. Hershey Medical Center, Dept of Family and Community Medicine | Hershey | Pennsylvania | 17033 | United States |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| D019602 |
| Food and Beverages |