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Probiotics in Primary Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01254097
First Posted: December 6, 2010
Last Update Posted: September 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
William Curry, Milton S. Hershey Medical Center
  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 Side Effect Dietary Supplement: Probiotic

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Feasibility Study of Probiotics in Primary Care

Resource links provided by NLM:


Further study details as provided by William Curry, Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Rate of antibiotic associated diarrhea [ Time Frame: 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:
  • Participant knowledge of probiotics [ Time Frame: At participant recruitment ]
    Assess current knowledge of probiotics of participants at the time of recruitment to study


Enrollment: 51
Study Start Date: March 2011
Study Completion Date: April 2014
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Florajen 3

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254097


Locations
United States, Pennsylvania
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
  More Information

Responsible Party: William Curry, Professor, Family and Community Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01254097     History of Changes
Other Study ID Numbers: Probiotic-1
First Submitted: December 3, 2010
First Posted: December 6, 2010
Last Update Posted: September 25, 2015
Last Verified: September 2015