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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
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile Infection focused on measuring probiotics, prebiotics, synbiotics

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
April 5, 2019
Last Updated
July 8, 2019
Sponsor
Hvidovre University Hospital
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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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