CDI Synbiotic Study

Hvidovre University Hospital

Status: Unknown

Conditions: Clostridium Difficile Infection

Treatments: Other: Placebo comparator; Dietary Supplement: Synbiotic mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT04012788

H-18041764

Details and patient eligibility

About

The investigators hypothesize that treatment with a synbiotic mixture consisting of inulin Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®) can reduce the number of C. difficile recurrences significantly.

Full 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®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®). However, most studies have focused on prevention of the first incidence of C. difficile infection rather than prevention of re-infection with C. difficile. Recurrence rates of C. difficile infection (CDI) among hospitalized patients are 15-25% - either as relapses caused by the original organism or re-infection following treatment. The potential of probiotics in preventing re-infection is less studied in these patients. Further, prebiotics which are carbohydrates only metabolized by beneficial bacteria have gained much attention the recent years for their health benefits through stimulating growth of specific types of bacteria in the gut, and recent data from mouse studies show that the prebiotic inulin can eliminate C. difficile growth, but the use of prebiotics in relation to C. difficile elimination has yet to be proven in humans. The investigators hypothesize that treatment with a synbiotic mixture consisting of inulin Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®) can reduce the number of C. difficile recurrences significantly.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with primary CDI
• Treatment with Vancomycin
• Subjects over 18 years of age
• Signed informed consent

Exclusion criteria

1. Chemotherapy within two months and an absolute neutrophil count of < 1000 neutrophiles/mm3
2. Acute leukemia
3. Serious immunodeficiency
4. Pancreatitis
5. Planned or recent intraabdominal operation within a time window of 14 days
6. Terminal disease with expected survival time < 3 month
7. Probiotic consumption within two weeks prior enrollment
8. Pregnant or lactating women
9. A history of inflammatory or irritable bowel disease
10. Colectomy and cirrhosis
11. Septicemia
12. Toxic megacolon

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

probiotic arm

Active Comparator group

Description:

inulin, 15 g Lactobacillus rhamnosus (LGG®) Lactobacillus acidophilus (LA-5®) Lactobacillus paracasei (L. casei 431®) Bifidobacterium lactis (BB-12®), Total cell counts 150 billion/day

Treatment:

Dietary Supplement: Synbiotic mixture

placebo arm

Placebo Comparator group

Description:

placebo powder, 15 g

Treatment:

Other: Placebo comparator