Can Probiotic Vivomixx Eradicate Colonization With ESBL?

Sponsor

Lund University (Other)

Overall Status

Completed

CT.gov ID

NCT03860415

Collaborator

(none)

Enrollment

Location

Arms

26.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Can probiotic Vivomixx eradicate Extended Spectrum BetaLactam (ESBL) colonization in adult patients?

Condition or Disease	Intervention/Treatment	Phase
Antibiotic Resistant Infection	Dietary Supplement: Vivomixx Dietary Supplement: Placebo	N/A

Detailed Description

Infections due to extended spectrum cephalosporin-resistant Enterobacteriaceae (ESCRE) are a widely recognized public health threat. The prevalence of ESCRE is comparably low in Sweden but is steadily increasing; approximately 5 % of Swedish inhabitants are carrying ESCRE in the gut. ESCRE can lead to infections mainly from urine, abdomen and blood. These infections can be problematic to treat with current available antibiotics and represent a clinical challenge for clinicians around the world with considerable mortality and morbidity. Risk factors for acquiring an ESCRE is e.g. antibiotic treatment, trips to high prevalence countries, family member with ESCRE etc.

The duration of ESCRE carriage is not known. One Swedish study showed that ESCRE carriage can continue despite antibiotic treatment and that false negative cultures in between positive cultures are common. Since few new groups of antibiotics have been developed in the last decades, infections due to ESCRE may be increasingly difficult to treat. The possibility of ESCRE decolonization is therefore a desirable aim, in particular the more virulent enterobacteriaceae strains leading to recurrent clinical infection episodes.

Probiotics are microorganisms marketed as useful bacteria effective locally in the gut. In recent years many studies have focused on potential health benefits in a range of different gastrointestinal diseases e.g. ulcerous colitis, Crohn's disease, antibiotic associated diarrhoea where probiotics potentially have a therapeutic role4. Smaller studies have shown that probiotics possibly can bind and eliminate enteric pathogenic bacteria5-6. A small in vitro study showed that probiotics can be effective against antibiotic resistant bacteria. Larger clinical treatment studies are needed.

ESCRE constitutes a clinical problem and is largely seen in Escherichia coli and klebsiella spp. The investigator's theory is that the probiotic Vivomixx can reject ESCRE and thus decolonize the gut. Vivomixx contains eight different strains of probiotics; Bifidobacterium breve, B. longum, B. infantis, Lactobacillus acidophilus, L. plantarum, L. paracasei, L. bulgaricus, Streptococcus thermophilus and has the best documentation in clinical studies for enteric diseases of today.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Probiotics as Intestinal Decolonization of ESBL-producing Enterobacteriaceae; a Randomized, Single Blinded, Placebo Controlled Clinical Trial

Actual Study Start Date :

Feb 1, 2017

Actual Primary Completion Date :

Apr 30, 2019

Actual Study Completion Date :

Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotic Vivomixx	Dietary Supplement: Vivomixx Two months of 2 sachets vivomixx each morning and 2 sachets each night. Each sachet of viviomixx contains 450 billion live bacteria.
Placebo Comparator: Placebo	Dietary Supplement: Placebo Two months of 2 sachets placebo each morning and 2 sachets each night. Each sachet of placebo contains 450 billion live bacteria.

Arm

Intervention/Treatment

Experimental: Probiotic

Vivomixx

Dietary Supplement: Vivomixx

Two months of 2 sachets vivomixx each morning and 2 sachets each night. Each sachet of viviomixx contains 450 billion live bacteria.

Placebo Comparator: Placebo

Dietary Supplement: Placebo

Two months of 2 sachets placebo each morning and 2 sachets each night. Each sachet of placebo contains 450 billion live bacteria.

Outcome Measures

Primary Outcome Measures

Rate of participants that have changed from ESBL-postitive to ESBL-negative. [After 12 months, the number of participants that have changed from ESBL-postitive to ESBL-negative will be assessed.]
Each patient included provides three faecal samples after the intervention which will be selectively cultured for ESBL. Rate of patients that have three negative ESBL cultures will be compared between the two groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Chronic (more than three months) ESBL colonization of the same strain as determined by
species, phenotype and antibiogram.
Patients must be able to swallow sachets.
Must be able to speak and understand Swedish.
Must have a permanent residence in Sweden.
Must be able to sign informed consent in Swedish.

Exclusion Criteria:

Immunosuppression (i.e. chemotheraphy, treatment with TNF-alpha-inhibitors).
In patient care.
immunodeficiency
psychiatric disorder
alcohol or substance abuse
dementia
Invasive catheters.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oskar Ljungquist	Helsingborg	Skåne	Sweden	25187

Sponsors and Collaborators

Lund University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lund University

ClinicalTrials.gov Identifier:

NCT03860415

Other Study ID Numbers:

2017-678678

First Posted:

Mar 4, 2019

Last Update Posted:

May 28, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 28, 2019