CDI Synbiotic Study
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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedJuly 9, 2019
July 1, 2019
10 months
April 5, 2019
July 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 year
Secondary Outcomes (1)
toxin A and B levels measured by qPCR
1 year
Study Arms (2)
probiotic arm
ACTIVE COMPARATORinulin, 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 arm
PLACEBO COMPARATORplacebo powder, 15 g
Interventions
A synbiotic mixture consisting of four probiotic strains and inulin (a prebiotic)
Eligibility Criteria
You may qualify if:
- Patients diagnosed with primary CDI
- Treatment with Vancomycin
- Subjects over 18 years of age
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hvidovre Hospital
Hvidovre, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas M Petersen
Gastrounit, Hvidovre Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Cosultant, PhD
Study Record Dates
First Submitted
April 5, 2019
First Posted
July 9, 2019
Study Start
July 1, 2019
Primary Completion
May 1, 2020
Study Completion
March 1, 2021
Last Updated
July 9, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share