Probiotics in Primary Care

Antibiotic Side Effect Clinical Trial

Official title:

Feasibility Study of Probiotics in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254097
• Other study ID #: Probiotic-1
• Status: Completed
• Phase: N/A
• First received: December 3, 2010
• Last updated: September 23, 2015
• Start date: March 2011
• Est. completion date: April 2014

Study information

• Verified date: September 2015
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 2014
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Antibiotic Side Effect

Intervention

Dietary Supplement:
• Probiotic
Probiotic capsule, 2 capsules twice daily

Locations

Country	Name	City	State
United States	M.S. Hershey Medical Center, Dept of Family and Community Medicine	Hershey,	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Participant knowledge of probiotics	Assess current knowledge of probiotics of participants at the time of recruitment to study	At participant recruitment	No