Probiotics in Primary Care

NCT ID: NCT01254097

Last Updated: 2015-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-04-30

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.

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.

Conditions

Antibiotic Side Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Probiotic

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

Group Type: PLACEBO_COMPARATOR

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Probiotic capsule, 2 capsules twice daily

Placebo

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

Group Type: PLACEBO_COMPARATOR

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Probiotic capsule, 2 capsules twice daily

Interventions

Probiotic

Probiotic capsule, 2 capsules twice daily

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Florajen 3

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

William Curry

Professor, Family and Community Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William J Curry, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

M.S. Hershey Medical Center, Dept of Family and Community Medicine

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

Probiotic-1

Identifier Type: -

Identifier Source: org_study_id