Open Label Trial of Nissle 1917

Urinary Tract Infections Clinical Trial

Official title:

Phase 1 Open Label Trial of Nissle 1917 to Assess Safety and Tolerance in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276508
• Other study ID #: IRB14-00586
• Status: Completed
• Phase: Phase 1
• First received: October 23, 2014
• Last updated: February 16, 2015
• Start date: October 2014
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

Drug:
• E. coli Nissle 1917
Participants will all take E. coli Nissle 1917 orally administered medication for 30 days

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Elizabeth Lucas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events associated with ingestion of E. coli Nissle 1917		30 days	Yes