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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01873872

Enrollment

120

Registered

2013-06-10

Start date

2013-07-31

Completion date

2014-03-31

Last updated

2014-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development of Clostridium Difficile Associated Diarrhea

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.

Interventions

DIETARY_SUPPLEMENTTheralac probiotic

DIETARY_SUPPLEMENTCulturelle probiotic

OTHERplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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 Post organ transplant Participants will be withdrawn from the study if they develop any of the

Design outcomes

Primary

Measure	Time frame
Development of Clostridium difficile associated diarrhea in patients receiving antibiotics	Up to six months

Countries

United States

Contacts

Primary ContactMark Middlebrooks, MD

markmiddlebrooks@bellsouth.net205-380-0848

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026