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CompletedNCT02276508Updated Feb 18, 2015

Open Label Trial of Nissle 1917

A Phase 1 interventional study of E. coli Nissle 1917 in Urinary Tract Infections, sponsored by Elizabeth Lucas. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-18.

Sponsored by Elizabeth Lucas · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Urinary Tract Infections
03

In context

Urinary Tract Infections

753 studies on the registry are indexed under Urinary Tract Infections; 128 are open to participants now.

This study's enrollment of 20 is below the median of 130 across 524 interventional studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

This is the only study on the registry with Elizabeth Lucas as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adult volunteer of age 21 years or older

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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

Interventions

  • DrugE. coli Nissle 1917

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

    Also known as: Mutaflor

06

What researchers measure

Primary outcomes

  1. Number of adverse events associated with ingestion of E. coli Nissle 1917

    Time frame: 30 days

07

Study locations

1 site
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02276508
Lead sponsor
Elizabeth Lucas
Responsible party
Elizabeth Lucas (Principal Invesgator, Nationwide Children's Hospital) — Sponsor-investigator
First posted
Oct 28, 2014
Start date
Oct 2014
Primary completion
Dec 2014
Completion
Feb 2015
Last update
Feb 18, 2015

Study contacts

Venkata R Jayanthi, MD
principal investigator · Nationwide Children's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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