Urinary Tract InfectionsPhase 1NCT02276508
Open Label Trial of Nissle 1917
A Phase 1 study testing E. coli Nissle 1917 in people with Urinary Tract Infections, run by Elizabeth Lucas at 1 site in United States.
Trial summary
Nissle 1917 is an E. coli based probiotic used in the Europe for close to 100 years to treat gastrointestinal disorders and infections. The investigators will assess the safety and tolerability of this medication in Americans in a Phase 1 trial. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- E. coli Nissle 1917
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Feb 2015
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteer of age 21 years or older
Who cannot join
- Any individual with an active urinary tract infection (UTI)
- Any individual with an acute illness within the past 7 days
- Any individual with neurogenic bladder or with vesicoureteral reflux
- Any individual with any anatomic abnormality, congenital or acquired, of the urinary tract system
- Any individual with any anatomic abnormality, congenital or acquired, of the gastrointestinal tract
- Any individual with untreated dysfunctional elimination syndrome
Show all 14Show fewer
- Immunocompromised patients
- Individuals with a central venous catheter
- Individuals requiring the use of antibiotics, immunomodulatory medications, or other probiotics
- Any participant with a history of chronic gastrointestinal disease
- Any individual with a chronic uncontrolled medical illness
- Any female of reproductive age who is currently pregnant, breastfeeding, or sexually active and unwilling or unable to use an acceptable method of contraception.
- Any participant is unable to appropriately take and store medication
- Any individual enrolled in a clinical trial evaluating another investigational agent in the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Phase 1 Open Label Trial of Nissle 1917 to Assess Safety and Tolerance in Healthy Adult Volunteers
Nissle 1917 is an E. coli based probiotic used in the Europe for close to 100 years to treat gastrointestinal disorders and infections. The investigators will assess the safety and tolerability of this medication in Americans in a Phase 1 trial.
Read the detailed description
Background: Nissle 1917 is an E. coli based probiotic that has been successfully used in Europe for close to 100 years to treat largely gastrointestinal disorders like inflammatory bowel disease, gastroenteritis, and irritable bowel syndrome. In addition to those disorders, we believe that Nissle 1917 is a promising alternative therapy for prevention of urinary tract infections in susceptible individuals.
Purpose: The Phase 1 trial will use Nissle 1917 in healthy adult patient volunteers for the first time in the United States. The investigators will track the frequency and incidence of side effects and adverse events.
Participants:
20 adult (>21 years of age) healthy volunteers
Protocol:
- Participants will enroll in our trial after a review of medical history and physical.
- Participants will then take 30 day course of Nissle 1917 capsules
- Investigators will telephone participants 1-2 weeks after they have begun the trial to assess for any side effects or adverse events
- Subjects will also be provided with a diary to record any side effects or adverse events
- At the end of 30 days, participants will return to clinic for a follow up visit to discuss any side effects or adverse events experienced during the trial and to return any unused medication
- Investigators will again telephone all participants 28-35 days following completion of the study drug again to pose a questionnaire aimed at revealing any side effects or adverse events.
- Conditions
- Urinary Tract Infections
- Being tested
- E. coli Nissle 1917
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E. coli Nissle 1917Drug
Also called Mutaflor
Participants will all take E. coli Nissle 1917 orally administered medication for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Participants will take the E. coli Nissle 1917 as an orally administered medication first while in clinic to be observed for 30 minutes for any hypersensitivity reaction. The dose of Nissle 1917 will be 100mg capsule (2.5-25x109 organism) once daily for a total of 4 days. Participants will then increase the dose to 2 capsules (200mg) once daily for the remaining 26 days of the study period. Receives: Drug: E. coli Nissle 1917 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events associated with ingestion of E. coli Nissle 1917
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Lucas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elizabeth Lucas, Nationwide Children's Hospital
- Investigators
- Venkata R Jayanthi, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276508
- Sponsor's protocol ID
- IRB14-00586
- Status last verified
- Feb 2015
- First submitted
- 23 Oct 2014
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Open Label Trial of Nissle 1917 to Assess Safety and Tolerance in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02276508
- Acronym / sponsor ID
- IRB14-00586
- Conditions
- Urinary Tract Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Elizabeth LucasUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 28 Oct 2014 (estimated)
- 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.
Nissle 1917 is an E. coli based probiotic used in the Europe for close to 100 years to treat gastrointestinal disorders and infections. The investigators will assess the safety and tolerability of this medication in Americans in a Phase 1 trial.
Detailed description
Background: Nissle 1917 is an E. coli based probiotic that has been successfully used in Europe for close to 100 years to treat largely gastrointestinal disorders like inflammatory bowel disease, gastroenteritis, and irritable bowel syndrome. In addition to those disorders, we believe that Nissle 1917 is a promising alternative therapy for prevention of urinary tract infections in susceptible individuals.
Purpose: The Phase 1 trial will use Nissle 1917 in healthy adult patient volunteers for the first time in the United States. The investigators will track the frequency and incidence of side effects and adverse events.
Participants:
20 adult (>21 years of age) healthy volunteers
Protocol:
- Participants will enroll in our trial after a review of medical history and physical.
- Participants will then take 30 day course of Nissle 1917 capsules
- Investigators will telephone participants 1-2 weeks after they have begun the trial to assess for any side effects or adverse events
- Subjects will also be provided with a diary to record any side effects or adverse events
- At the end of 30 days, participants will return to clinic for a follow up visit to discuss any side effects or adverse events experienced during the trial and to return any unused medication
- Investigators will again telephone all participants 28-35 days following completion of the study drug again to pose a questionnaire aimed at revealing any side effects or adverse events.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Drug: E. coli Nissle 1917Participants will take the E. coli Nissle 1917 as an orally administered medication first while in clinic to be observed for 30 minutes for any hypersensitivity reaction. The dose of Nissle 1917 will be 100mg capsule (2.5-25x109 organism) once daily for a total of 4 days. Participants will then increase the dose to 2 capsules (200mg) once daily for the remaining 26 days of the study period. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult volunteer of age 21 years or older
Key exclusion criteria (14 listed)
- Any individual with an active urinary tract infection (UTI)
- Any individual with an acute illness within the past 7 days
- Any individual with neurogenic bladder or with vesicoureteral reflux
- Any individual with any anatomic abnormality, congenital or acquired, of the urinary tract system
- Any individual with any anatomic abnormality, congenital or acquired, of the gastrointestinal tract
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 |
|---|---|---|
| E. coli Nissle 1917Also: MutaflorParticipants will all take E. coli Nissle 1917 orally administered medication for 30 days | Drug | Probiotic |
Primary outcome
Number of adverse events associated with ingestion of E. coli Nissle 1917
Time frame: 30 days
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 18 Feb 2015.
Related trials for Urinary Tract Infections
Recruiting
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
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.
Venkata R Jayanthi, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E. coli Nissle 1917 in people with Urinary Tract Infections, run by Elizabeth Lucas at 1 site in United States.
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 1 inclusion and 14 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 18 Feb 2015. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of adverse events associated with ingestion of E. coli Nissle 1917 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2015.