Probiotics in Primary Care
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Milton S. Hershey Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Milton S. Hershey Medical Center
Information provided by:
Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01254097
First received: December 3, 2010
Last updated: July 20, 2011
Last verified: November 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Antibiotic Therapy |
Dietary Supplement: Probiotic |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Feasibility Study of Probiotics in Primary Care |
Resource links provided by NLM:
Further study details as provided by Milton S. Hershey Medical Center:
Primary Outcome Measures:
- Rate of antibiotic associated diarrhea [ Time Frame: two weeks after start of antibiotics ] [ Designated as safety issue: No ]Groups will be compared based on rates of antibiotic associated diarrhea, symptoms developing in the two week window of when antibiotics are started.
Secondary Outcome Measures:
- Participant knowledge of probiotics [ Time Frame: At participant recruitment ] [ Designated as safety issue: No ]Assess current knowledge of probiotics of participants at the time of recruitment to study
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Probiotic
Participants are provided in double blinded fashion, either probiotic or placebo to take with antibiotics prescribed by their provider.
|
Dietary Supplement: Probiotic
Probiotic capsule, 2 capsules twice daily
Other Name: Florajen 3, probiotic containing Lactobacillus acidophilus, Bifidobacterium lactis and Bifidobacterium longum
|
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254097
Contacts
| Contact: William J Curry, MD, MS | 717-531-8736 | wcurry@psu.edu |
| Contact: Marie A Graybill, RN | 717-531-8736 | mgraybill@psu.edu |
Locations
| United States, Pennsylvania | |
| M.S. Hershey Medical Center, Dept of Family and Community Medicine | Recruiting |
| Hershey,, Pennsylvania, United States, 17033 | |
| Contact: William J Curry, MD, MS 717-531-8736 wcurry@psu.edu | |
Sponsors and Collaborators
Milton S. Hershey Medical Center
More Information
No publications provided
| Responsible Party: | William Curry, MD, Penn State Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT01254097 History of Changes |
| Other Study ID Numbers: | Probiotic-1 |
| Study First Received: | December 3, 2010 |
| Last Updated: | July 20, 2011 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 16, 2013