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

Not Applicable

• Conditions: Development of Clostridium Difficile Associated Diarrhea
• Interventions: Dietary Supplement: Theralac probiotic; Dietary Supplement: Culturelle probiotic; Other: placebo

• Registration Number: NCT01873872
• Lead Sponsor: St. Vincent's East, Birmingham, Alabama

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2013-06
• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-10
• Study Start: 2013-07
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-26
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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Participants will be withdrawn from the study if they develop any of the exclusion criteria during the hospitalization.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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Theralac probiotic	Theralac probiotic	-
Culturelle probiotic	Culturelle probiotic	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Development of Clostridium difficile associated diarrhea in patients receiving antibiotics	Up to six months

Trial Locations

Locations (1)

St. Vincent's East; 🇺🇸 Birmingham, Alabama, United States