CDI Synbiotic Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-31

Study Completion Date

2021-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Clostridium Difficile Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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probiotic arm

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

Group Type ACTIVE_COMPARATOR

Synbiotic mixture

Intervention Type DIETARY_SUPPLEMENT

A synbiotic mixture consisting of four probiotic strains and inulin (a prebiotic)

placebo arm

placebo powder, 15 g

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type OTHER

Placebo powder

Interventions

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Synbiotic mixture

A synbiotic mixture consisting of four probiotic strains and inulin (a prebiotic)

Intervention Type DIETARY_SUPPLEMENT

Placebo comparator

Placebo powder

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No