CDI Synbiotic Study
Primary Purpose
Clostridium Difficile Infection
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Synbiotic mixture
Placebo comparator
Sponsored by
About this trial
This is an interventional prevention trial for Clostridium Difficile Infection focused on measuring probiotics, prebiotics, synbiotics
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with primary CDI
- Treatment with Vancomycin
- Subjects over 18 years of age
- Signed informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Hvidovre HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
probiotic arm
placebo arm
Arm 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
placebo powder, 15 g
Outcomes
Primary Outcome Measures
Reduced recurrence of C. difficile-associated diarrhoea (CDAD) after 8 weeks
telephone questionnaire with patient at end of trial as well as examination of each patient's medical record
Secondary Outcome Measures
toxin A and B levels measured by qPCR
Full Information
NCT ID
NCT04012788
First Posted
April 5, 2019
Last Updated
July 8, 2019
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04012788
Brief Title
CDI Synbiotic Study
Official Title
The Effectiveness of a Synbiotic Mixture (Inulin, Lactobacillus Rhamnosus (LGG®), Lactobacillus Acidophilus (LA-5®), Lactobacillus Paracasei, and Bifidobacterium Lactis (BB-12®)), on Decreasing Recurrence of Clostridium Difficile Associated Diarrhea- a , Randomized, Placebo-controlled Study With 4 Weeks Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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®) and Bifidobacterium lactis (BB-12®) can reduce the number of C. difficile recurrences significantly.
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®), 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
Keywords
probiotics, prebiotics, synbiotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
probiotic arm
Arm Type
Active Comparator
Arm 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
Arm Title
placebo arm
Arm Type
Placebo Comparator
Arm Description
placebo powder, 15 g
Intervention Type
Dietary Supplement
Intervention Name(s)
Synbiotic mixture
Intervention Description
A synbiotic mixture consisting of four probiotic strains and inulin (a prebiotic)
Intervention Type
Other
Intervention Name(s)
Placebo comparator
Intervention Description
Placebo powder
Primary Outcome Measure Information:
Title
Reduced recurrence of C. difficile-associated diarrhoea (CDAD) after 8 weeks
Description
telephone questionnaire with patient at end of trial as well as examination of each patient's medical record
Time Frame
1 year
Secondary Outcome Measure Information:
Title
toxin A and B levels measured by qPCR
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with primary CDI
Treatment with Vancomycin
Subjects over 18 years of age
Signed informed consent
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas M Petersen
Phone
004538626199
Email
andreas.munk.petersen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Maria IC Rubin
Email
ingrid.maria.cecilia.rubin@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas M Petersen
Organizational Affiliation
Gastrounit, Hvidovre Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre Hospital
City
Hvidovre
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas M Petersen
12. IPD Sharing Statement
Plan to Share IPD
No
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CDI Synbiotic Study
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