CDI Synbiotic Study | NCT04012788

Studies
CDI Synbiotic Study

NCT04012788

Sponsor

Hvidovre University Hospital

Status

Unknown status

Last Update Posted

Jul 9, 2019Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Clostridium Difficile Infection

Interventions

Synbiotic mixture
Placebo comparator

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2019Estimated

Primary Completion Date

May 1, 2020Estimated

Completion Date

Mar 1, 2021Estimated

First Submitted Date

Apr 5, 2019

First Submission Date that Met QC Criteria

Jul 8, 2019

First Posted Date

Jul 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2019

Last Update Posted Date

Jul 9, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andreas Munk Petersen, MD, Cosultant, PhD, Hvidovre University HospitalPrincipal Investigator

Lead Sponsor

Hvidovre University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
probiotic arm	Active Comparator	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
placebo arm	Placebo Comparator	placebo powder, 15 g	Other: Placebo comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Synbiotic mixture	Dietary Supplement	A synbiotic mixture consisting of four probiotic strains and inulin (a prebiotic)	probiotic arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
toxin A and B levels measured by qPCR		1 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andreas M Petersen	Contact	004538626199		andreas.munk.petersen@regionh.dk
Maria IC Rubin	Contact			ingrid.maria.cecilia.rubin@regionh.dk

Overall Officials

Name	Affiliation	Role
Andreas M Petersen	Gastrounit, Hvidovre Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre Hospital	Recruiting	Hvidovre			Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003015	Clostridium Infections

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

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Browse Branches

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