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

St. Vincent's East, Birmingham, Alabama

Status: Unknown

Conditions: Development of Clostridium Difficile Associated Diarrhea

Treatments: Dietary Supplement: Theralac probiotic; Other: placebo; Dietary Supplement: Culturelle probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT01873872

PROBIOTIC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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Participants will be withdrawn from the study if they develop any of the exclusion criteria during the hospitalization.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

120 participants in 3 patient groups, including a placebo group

Theralac probiotic

Active Comparator group

Treatment:

Dietary Supplement: Theralac probiotic

Culturelle probiotic

Active Comparator group

Treatment:

Dietary Supplement: Culturelle probiotic

Placebo

Placebo Comparator group

Treatment:

Other: placebo