Clostridium Difficile
Conditions
Keywords
Clostridium difficile, Diarrhea, Infection, Lactobacilli, Bifidobacteria, Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium lactis, Yogurt, Probiotics
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
The intervention will consist of the subject taking the study medication once a day for 4 weeks. During hospitalization, patients will be followed daily for diarrhea history, record of concomitant medications, adverse effects (AEs), and their response to treatment using a stool diary. Upon discharge from the hospital, patients will be contacted through weekly phone calls to assess diarrhea history, record of concomitant medications, adverse effects (AEs), and their response to treatment using a stool diary. At weeks 4 and 8, a stool sample will be collected, and the stool diary will be reviewed.
DIETARY_SUPPLEMENTPlacebo
The intervention will consist of the subject taking the placebo once a day for 4 weeks. day for 4 weeks. During hospitalization, patients will be followed daily for diarrhea history, record of concomitant medications, adverse effects (AEs), and their response to treatment using a stool diary. Upon discharge from the hospital, patients will be contacted through weekly phone calls to assess diarrhea history, record of concomitant medications, adverse effects (AEs), and their response to treatment using a stool diary. At weeks 4 and 8, a stool sample will be collected, and the stool diary will be reviewed.
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of diarrhea | 4 weeks | Duration of diarrhea, as indicated by a stool diary kept by the patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infection with Lactobacillus | 8 weeks | Fever and other signs of infection with Lactobacillus, and infection confirmed through blood cultures |
| Infection with Bifidobacterium | 8 weeks | Fever and other signs of infection with Bifidobacterium, and infection confirmed through blood cultures |
Countries
United States
Outcome results
None listed