Open Label Trial of Nissle 1917
Completed · Phase 1
Conditions studied: Urinary Tract Infections
In brief
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.
Key facts
- Study ID
- NCT02276508
- Run by
- Elizabeth Lucas
- People needed
- 20
- Starts
- 2014-10-01
- Expected to finish
- 2015-02-01
- Last updated by the study team
- 2015-02-18
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy adult volunteer of age 21 years or older
You may not qualify if…
- 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.
Where it is running
- Nationwide Children's Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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