Can Probiotic Vivomixx Eradicate Colonization With ESBL?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Supplementation of Standard Antibiotic Therapy With Oral Probiotics for Bacterial Vaginosis

NCT01993524

Bacterial Vaginosis Bacterial Vaginitis

COMPLETED NA

The Efficacy of Probiotics as an Adjunct to Treatment of SIBO With Rifaximin

NCT06223685

Irritable Bowel Syndrome Small Intestinal Bacterial Overgrowth SIBO

COMPLETED NA

Interventional Study to Evaluate the Effect of the Oral Administration of L.Plantarum on Vaginal Microbiota

NCT04461782

Vaginal Infection

COMPLETED NA

Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

NCT04118049

Pelvic Organ Prolapse Inflammatory Response Dysbiosis

COMPLETED NA

Investigating the Impact of Humiome B2 (Colon Delivered Riboflavin) and Riboflavin-overproducer Probiotic Strain Limosilactobacillus Reuteri AMBV339 on Intestinal and Vaginal Microbiome and Health of Healthy Adult Women (The VIAB2L Project)

NCT06425081

Microbial Colonization

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antibiotic Resistant Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probiotic

Vivomixx

Group Type EXPERIMENTAL

Vivomixx

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vivomixx

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

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes