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出境医 / 临床实验 / CDI Synbiotic Study

CDI Synbiotic Study

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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Dietary Supplement: Synbiotic mixture Other: Placebo comparator Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : March 1, 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: 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
 Dietary Supplement: Synbiotic mixture
A synbiotic mixture consisting of four probiotic strains and inulin (a prebiotic)
Placebo Comparator: placebo arm
placebo powder, 15 g
 Other: Placebo comparator
Placebo powder
Outcome Measures
Primary Outcome Measures :
  1. Reduced recurrence of C. difficile-associated diarrhoea (CDAD) after 8 weeks [ Time Frame: 1 year ]
    telephone questionnaire with patient at end of trial as well as examination of each patient's medical record


Secondary Outcome Measures :
  1. toxin A and B levels measured by qPCR [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Andreas M Petersen 004538626199 andreas.munk.petersen@regionh.dk
Contact: Maria IC Rubin ingrid.maria.cecilia.rubin@regionh.dk

Locations
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Denmark
Hvidovre Hospital Recruiting
Hvidovre, Denmark
Contact: Andreas M Petersen         
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Principal Investigator: Andreas M Petersen Gastrounit, Hvidovre Hospital
Tracking Information
First Submitted Date  ICMJE April 5, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		Reduced recurrence of C. difficile-associated diarrhoea (CDAD) after 8 weeks [ Time Frame: 1 year ]
telephone questionnaire with patient at end of trial as well as examination of each patient's medical record
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		toxin A and B levels measured by qPCR [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CDI Synbiotic Study
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Clostridium Difficile Infection
Intervention  ICMJE
  • Dietary Supplement: Synbiotic mixture
    A synbiotic mixture consisting of four probiotic strains and inulin (a prebiotic)
  • Other: Placebo comparator
    Placebo powder
Study Arms  ICMJE
  • Active Comparator: 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
    Intervention: Dietary Supplement: Synbiotic mixture
  • Placebo Comparator: placebo arm
    placebo powder, 15 g
    Intervention: Other: Placebo comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andreas M Petersen 004538626199 andreas.munk.petersen@regionh.dk
Contact: Maria IC Rubin ingrid.maria.cecilia.rubin@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012788
Other Study ID Numbers  ICMJE H-18041764
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andreas Munk Petersen, Hvidovre University Hospital
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas M Petersen Gastrounit, Hvidovre Hospital
PRS Account Hvidovre University Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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