Status:
UNKNOWN
CDI Synbiotic Study
Lead Sponsor:
Hvidovre University Hospital
Conditions:
Clostridium Difficile Infection
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The investigators hypothesize that treatment with a synbiotic mixture consisting of inulin Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) an...
Detailed Description
Probiotics have been tested for their efficacy in preventing infection with C. difficile after antibiotic exposure. Some of the most effective probiotics tested Lactobacillus rhamnosus (LGG®), Lactoba...
Eligibility Criteria
Inclusion
- Patients diagnosed with primary CDI
- Treatment with Vancomycin
- Subjects over 18 years of age
- Signed informed consent
Exclusion
- Chemotherapy within two months and an absolute neutrophil count of \< 1000 neutrophiles/mm3
- Acute leukemia
- Serious immunodeficiency
- Pancreatitis
- Planned or recent intraabdominal operation within a time window of 14 days
- Terminal disease with expected survival time \< 3 month
- Probiotic consumption within two weeks prior enrollment
- Pregnant or lactating women
- A history of inflammatory or irritable bowel disease
- Colectomy and cirrhosis
- Septicemia
- Toxic megacolon
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04012788
Start Date
July 1 2019
End Date
March 1 2021
Last Update
July 9 2019
Active Locations (1)
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1
Hvidovre Hospital
Hvidovre, Denmark