Trials / Completed
CompletedNCT01254097
Probiotics in Primary Care
Feasibility Study of Probiotics in Primary Care
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Milton S. Hershey Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Probiotic | Probiotic capsule, 2 capsules twice daily |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2011-07-01
- Completion
- 2014-04-01
- First posted
- 2010-12-06
- Last updated
- 2015-09-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01254097. Inclusion in this directory is not an endorsement.