Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 4/2/2016 |
| Start Date: | July 2013 |
| End Date: | March 2014 |
| Contact: | Mark Middlebrooks, MD |
| Email: | markmiddlebrooks@bellsouth.net |
| Phone: | 205-380-0848 |
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.
available probiotics, on the incidence of Clostridium difficile-associated diarrhea
in a population of general inpatients who are receiving antibiotics.
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.
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.
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Participants will be withdrawn from the study if they develop any of the exclusion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.
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