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
Sponsor:
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
  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 April 23, 2014