Antibiotic Resistant InfectionNCT03860415
Can Probiotic Vivomixx Eradicate Colonization With ESBL?
A study testing Vivomixx in people with Antibiotic Resistant Infection, run by Lund University at 1 site in Sweden.
Trial summary
Can probiotic Vivomixx eradicate Extended Spectrum BetaLactam (ESBL) colonization in adult patients? Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Resistant Infection
- What is being tested?
- Vivomixx
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2017to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Immunosuppression (i.e. chemotheraphy, treatment with TNF-alpha-inhibitors).
- In patient care.
- immunodeficiency
- psychiatric disorder
- alcohol or substance abuse
- dementia
- Invasive catheters.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics as Intestinal Decolonization of ESBL-producing Enterobacteriaceae; a Randomized, Single Blinded, Placebo Controlled Clinical Trial
Can probiotic Vivomixx eradicate Extended Spectrum BetaLactam (ESBL) colonization in adult patients?
Read the 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.
- Conditions
- Antibiotic Resistant Infection
- Being tested
- Vivomixx, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VivomixxDietary supplement
Two months of 2 sachets vivomixx each morning and 2 sachets each night. Each sachet of viviomixx contains 450 billion live bacteria.
PlaceboDietary supplement
Two months of 2 sachets placebo each morning and 2 sachets each night. Each sachet of placebo contains 450 billion live bacteria.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Vivomixx Receives: Dietary Supplement: Vivomixx |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 12 months, the number of participants that have changed from ESBL-postitive to ESBL-negative will be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start1 Feb 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Resistant InfectionStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860415
- Sponsor's protocol ID
- 2017-678678
- Other IDs
- 2017
- Status last verified
- May 2019
- First submitted
- 25 Feb 2019
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31494254
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics as Intestinal Decolonization of ESBL-producing Enterobacteriaceae; a Randomized, Single Blinded, Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03860415
- Acronym / sponsor ID
- 2017-678678
- Conditions
- Antibiotic Resistant Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Can probiotic Vivomixx eradicate Extended Spectrum BetaLactam (ESBL) colonization in adult patients?
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: VivomixxVivomixx |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- Immunosuppression (i.e. chemotheraphy, treatment with TNF-alpha-inhibitors).
- In patient care.
- immunodeficiency
- psychiatric disorder
- alcohol or substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VivomixxTwo months of 2 sachets vivomixx each morning and 2 sachets each night. Each sachet of viviomixx contains 450 billion live bacteria. | Dietary supplement | Probiotic |
| PlaceboTwo months of 2 sachets placebo each morning and 2 sachets each night. Each sachet of placebo contains 450 billion live bacteria. | Dietary supplement | Placebo |
Primary outcome
Rate of participants that have changed from ESBL-postitive to ESBL-negative.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Derived from this study: PubMed 31494254Ljungquist 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivomixx in people with Antibiotic Resistant Infection, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participants that have changed from ESBL-postitive to ESBL-negative. (time frame: After 12 months, the number of participants that have changed from ESBL-postitive to ESBL-negative will be assessed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03860415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.