Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics

Development of Clostridium Difficile Associated Diarrhea Clinical Trial

Official title:

Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01873872
• Other study ID #: PROBIOTIC
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2013
• Last updated: March 26, 2014
• Start date: July 2013
• Est. completion date: March 2014

Study information

• Verified date: June 2013
• Source: St. Vincent's East, Birmingham, Alabama
• Contact: Mark Middlebrooks, MD
• Phone: 205-380-0848
• Email: markmiddlebrooks[@]bellsouth.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

We have designed this study to measure the effect of normal flora supplementation, using available probiotics, on the incidence of Clostridium difficile-associated diarrhea

in a population of general inpatients who are receiving antibiotics.

Description:

General medical-surgical patients in a community hospital who are receiving antibiotics, and who agree to participate, will be given one of two different probiotics, or placebo. Data will be gathered during their hospitalization, and at one and three months following hospital discharge. We expect to see a lower incidence of Clostridium difficile-associated diarrhea in the probiotic groups when compared to the placebo group. We will also be looking for differences between the effects of the two probiotics, which differ in strain types and number of colony forming units per dose.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria: Any hospitalized patient who is age 19 or older and receiving antibiotics.

Exclusion Criteria:

• Feeding tube in place

• Pregnancy

• Milk or soy allergy

• Sensitivity to lactose

• Immunocompromised defined as:

1. Absolute neutrophil count (ANC) = 500 cells/mm3

2. HIV

3. Cancer patient receiving chemotherapy or radiation therapy

4. Immune deficiency

5. Post organ transplant

Participants will be withdrawn from the study if they develop any of the exclusion criteria during the hospitalization.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Development of Clostridium Difficile Associated Diarrhea
• Diarrhea

Intervention

Dietary Supplement:
• Theralac probiotic

• Culturelle probiotic

Other:
• placebo

Locations

Country	Name	City	State
United States	St. Vincent's East	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
St. Vincent's East, Birmingham, Alabama	Master Supplements, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Clostridium difficile associated diarrhea in patients receiving antibiotics		Up to six months	No