Open Label Trial of Nissle 1917

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Drug: E. coli Nissle 1917

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Probiotic; 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.

Drug: E. coli Nissle 1917; Participants will all take E. coli Nissle 1917 orally administered medication for 30 days; Other Names: Mutaflor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events associated with ingestion of E. coli Nissle 1917	30 days

Collaborators and Investigators

• Sponsor: Elizabeth Lucas
• Investigators: Principal Investigator: Venkata R Jayanthi, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: October 27, 2014
• First Posted (Estimate): October 28, 2014

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 16, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections
• Other Study ID Numbers: IRB14-00586