Status:
COMPLETED
Open Label Trial of Nissle 1917
Lead Sponsor:
Elizabeth Lucas
Conditions:
Urinary Tract Infections
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief 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 thi...
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, gast...
Eligibility Criteria
Inclusion
- Healthy adult volunteer of age 21 years or older
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02276508
Start Date
October 1 2014
End Date
February 1 2015
Last Update
February 18 2015
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205