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Open Label Trial of Nissle 1917

Sponsor
Elizabeth Lucas (Other)
Overall Status
Completed
CT.gov ID
NCT02276508
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
4
Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: E. coli Nissle 1917
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Phase 1 Open Label Trial of Nissle 1917 to Assess Safety and Tolerance in Healthy Adult Volunteers
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of adverse events associated with ingestion of E. coli Nissle 1917 [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nationwide Children's Hospital Columbus Ohio United States 43205

    Sponsors and Collaborators

    • Elizabeth Lucas

    Investigators

    • Principal Investigator: Venkata R Jayanthi, MD, Nationwide Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elizabeth Lucas, Principal Invesgator, Nationwide Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT02276508
    Other Study ID Numbers:
    • IRB14-00586
    First Posted:
    Oct 28, 2014
    Last Update Posted:
    Feb 18, 2015
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:
    Urinary Tract Infections

    Study Results

    No Results Posted as of Feb 18, 2015