Open Label Trial of Nissle 1917

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Elizabeth Lucas

Criteria

Inclusion Criteria:

• Healthy adult volunteer of age 21 years or older

Exclusion Criteria:

• 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.