NCT03860415

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

2.2 years

First QC Date

February 25, 2019

Last Update Submit

May 23, 2019

Conditions

Antibiotic Resistant Infection

Outcome Measures

Primary Outcomes (1)

  • Rate of participants that have changed from ESBL-postitive to ESBL-negative.

    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.

    After 12 months, the number of participants that have changed from ESBL-postitive to ESBL-negative will be assessed.

Study Arms (2)

Probiotic

EXPERIMENTAL

Vivomixx

Dietary Supplement: Vivomixx

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

VivomixxDIETARY_SUPPLEMENT

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

Probiotic
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oskar Ljungquist

Helsingborg, Skåne County, 25187, Sweden

Location

Related Publications (1)

  • Ljungquist O, Kampmann C, Resman F, Riesbeck K, Tham J. Probiotics for intestinal decolonization of ESBL-producing Enterobacteriaceae: a randomized, placebo-controlled clinical trial. Clin Microbiol Infect. 2020 Apr;26(4):456-462. doi: 10.1016/j.cmi.2019.08.019. Epub 2019 Sep 5.

    PMID: 31494254DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 4, 2019

Study Start

February 1, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations

SE(1)