Probiotics in Primary Care

Not Applicable

Completed

• Conditions: Antibiotic Side Effect
• Interventions: Dietary Supplement: Probiotic

• Registration Number: NCT01254097
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-06
• Study Start: 2011-03
• Primary Completion: 2011-07
• Study Completion: 2014-04
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-23
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Participants are provided in double blinded fashion, probiotic given to take with antibiotics prescribed by their provider.
Placebo	Probiotic	Participants are provided in double blinded fashion, Look alike placebo given to take with antibiotics prescribed by their provider.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Participant knowledge of probiotics	At participant recruitment	Assess current knowledge of probiotics of participants at the time of recruitment to study

Trial Locations

Locations (1)

M.S. Hershey Medical Center, Dept of Family and Community Medicine; 🇺🇸 Hershey,, Pennsylvania, United States