Probiotics in Primary Care

Feasibility Study of Probiotics in Primary Care

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.

Study Overview

• Status: Completed
• Conditions: Antibiotic Side Effect
• Intervention / Treatment: Dietary supplement: Probiotic

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey,, Pennsylvania, United States, 17033
      • M.S. Hershey Medical Center, Dept of Family and Community Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant knowledge of probiotics	Assess current knowledge of probiotics of participants at the time of recruitment to study	At participant recruitment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: December 3, 2010
• First Submitted That Met QC Criteria: December 3, 2010
• First Posted (ESTIMATE): December 6, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 25, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: Probiotic-1