Probiotics in Primary Care
Feasibility Study of Probiotics in Primary Care
1 other identifier
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2010
CompletedFirst Posted
Study publicly available on registry
December 6, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedSeptember 25, 2015
September 1, 2015
4 months
December 3, 2010
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Participant knowledge of probiotics
At participant recruitment
Study Arms (2)
Probiotic
PLACEBO COMPARATORParticipants are provided in double blinded fashion, probiotic given to take with antibiotics prescribed by their provider.
Placebo
PLACEBO COMPARATORParticipants are provided in double blinded fashion, Look alike placebo given to take with antibiotics prescribed by their provider.
Interventions
Probiotic capsule, 2 capsules twice daily
Eligibility Criteria
You may qualify if:
- adults 18 - 79 years of age with infection requiring an oral antibiotic.
- Must be able to be contacted via telephone.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M.S. Hershey Medical Center, Dept of Family and Community Medicine
Hershey, Pennsylvania, 17033, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William J Curry, MD, MS
Milton S. Hershey Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Family and Community Medicine
Study Record Dates
First Submitted
December 3, 2010
First Posted
December 6, 2010
Study Start
March 1, 2011
Primary Completion
July 1, 2011
Study Completion
April 1, 2014
Last Updated
September 25, 2015
Record last verified: 2015-09