Clincosm LogoSign in Get a demo

Probiotics in Primary Care

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01254097
Collaborator
(none)
51
Enrollment
1
Location
2
Arms
37
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Feasibility Study of Probiotics in Primary Care
Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Probiotic

Participants are provided in double blinded fashion, probiotic given to take with antibiotics prescribed by their provider.

Dietary Supplement: Probiotic
Probiotic capsule, 2 capsules twice daily
Other Names:
  • Florajen 3

    		•
    Placebo Comparator: Placebo

    Participants are provided in double blinded fashion, Look alike placebo given to take with antibiotics prescribed by their provider.

    Dietary Supplement: Probiotic
    Probiotic capsule, 2 capsules twice daily
    Other Names:
  • Florajen 3

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of antibiotic associated diarrhea [two weeks after start of antibiotics]

      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

    1. Participant knowledge of probiotics [At participant recruitment]

      Assess current knowledge of probiotics of participants at the time of recruitment to study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 M.S. Hershey Medical Center, Dept of Family and Community Medicine Hershey, Pennsylvania United States 17033

    Sponsors and Collaborators

    • Milton S. Hershey Medical Center

    Investigators

    • Principal Investigator: William J Curry, MD, MS, Milton S. Hershey Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    William Curry, Professor, Family and Community Medicine, Milton S. Hershey Medical Center
    ClinicalTrials.gov Identifier:
    NCT01254097
    Other Study ID Numbers:
    • Probiotic-1
    First Posted:
    Dec 6, 2010
    Last Update Posted:
    Sep 25, 2015
    Last Verified:
    Sep 1, 2015

    Study Results

    No Results Posted as of Sep 25, 2015