Probiotics for Clostridium Difficile Infection in Older Adults
- Conditions
- Clostridium Difficile
- Interventions
- Dietary Supplement: ProbioticDietary Supplement: Placebo
- Registration Number
- NCT01680874
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
The purpose of this study is to determine whether a probiotic, when used together with standard treatment, is effective in reducing duration of symptoms and preventing recurrence of infection in older adults with a first episode of C. difficile infection.
- Detailed Description
Probiotics are live microorganisms that are available over the counter, widely used as dietary supplements or nutritional foods, and represent a low-cost, well tolerated, safe, non-antibiotic based strategy that may have efficacy as adjunctive treatment of infections without the attendant risks of promoting antimicrobial resistance. Certain probiotics have demonstrated inhibition of adherence of pathogenic bacteria and stimulation of systemic immune functions, possibly enhancing the body's ability to eradicate C. difficile in the gastrointestinal tract. However, limited data is available on the efficacy of probiotics for ameliorating C. difficile symptoms and reducing recurrence of C. difficile infection (CDI). The investigators propose a pilot randomized, double-blind, placebo-controlled clinical trial in older adult inpatients with a first episode of CDI to evaluate the efficacy of a probiotic combination, in conjunction with standard treatment, for reducing duration of diarrhea and recurrence of CDI.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Adult of either gender, 18 years or older with a first episode of C. difficile infection
- Meets the case definition of C. difficile infection-diarrhea associated with a positive stool test for C. difficile toxin(s) in the 2 days prior to enrollment treated with metronidazole or vancomycin
- Severe disease defined as any of the following: WBC > 30,000 or < 1000 cells/mm^3, elevated creatinine > 1.5 times the premorbid level, ICU patient at time C. difficile infection diagnosed
- Has other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal disease)
- Has a history of chronic intestinal disease (e.g. Crohn's disease, ulcerative colitis)
- Has a presence of toxic megacolon or ileus
- Has a presence of colostomy or nasogastric tube
- Has a history of abdominal surgery within the previous 3 months (from time of enrollment)
- Is enrolled in another investigational drug trial
- Is unavailable for follow-up visits
- History of multiple C. difficile infection
- Willing not to take other probiotics for duration of study
- Is severely immunocompromised.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotic Probiotic This arm will receive a probiotic combination which will consist of equal amounts of Lactobacillus acidophilus NCFM® (ATCC 700396), Lactobacillus paracasei Lpc-37 (ATCC SD5275), Bifidobacterium lactis Bi-07 (ATCC SC5220), and Bifidobacterium lactis Bl-04 (ATCC SD5219). The probiotic will be taken orally, once a week, for 4 weeks. Placebo Placebo A placebo will be taken orally, once a day, for 4 weeks.
- Primary Outcome Measures
Name Time Method Duration of diarrhea 4 weeks Duration of diarrhea, as indicated by a stool diary kept by the patient
- Secondary Outcome Measures
Name Time Method Density of C. difficile toxin in stool 8 weeks Stool cytokines 8 weeks Fecal lactoferrin 8 weeks Functional assessment using Barthel Index 8 weeks Recurrence of CDI 8 weeks Diagnosis with a recurrent episode of C. difficile infection
Trial Locations
- Locations (1)
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States