Recruiting

Probiotics

Sponsor:

St. Vincent's East, Birmingham, Alabama

Code:

NCT01873872

Conditions

Development of Clostridium Difficile Associated Diarrhea

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Interventions

Theralac probiotic

Culturelle probiotic

placebo

Study Details

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.

Conditions

Development of Clostridium Difficile Associated Diarrhea

Study ID

NCT01873872

Start date

Jul, 2013

Status verified date

Jun, 2013

Completion date

Mar, 2014

Anticipated

Primary completion date

Mar, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

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

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Participants will be withdrawn from the study if they develop any of the exclusion criteria during the hospitalization.

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Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Theralac probiotic

active comparator: Culturelle probiotic

placebo comparator: Placebo

Interventions

Theralac probiotic

Culturelle probiotic

placebo

Primary outcome measure

  • Development of Clostridium difficile associated diarrhea in patients receiving antibiotics [ Time Frame: Up to six months ]

Central Contacts and Locations

Central contacts

Mark Middlebrooks, MD

205-380-0848markmiddlebrooks@bellsouth.net

Locations

St. Vincent's East

Recruiting

Birmingham, Alabama, United States, 35235

Contacts

Leanne Phillips, Pharm.D

205-838-3109leanne.phillips@stvhs.com

Mark Middlebrooks, MD

205-380-0848markmiddlebrooks@bellsouth.net

Principal Investigator:

Mark Middlebrooks, MD

More Information

Sponsor

St. Vincent's East, Birmingham, Alabama

Last update posted

Mar 28, 2014

Last verified

Jun, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Vincent's East, Birmingham, Alabama on 2014-03-28.