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Open Label Trial of Nissle 1917

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276508
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
Elizabeth Lucas, Nationwide Children's Hospital

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
Urinary Tract Infections 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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


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 Name: Mutaflor




Primary Outcome Measures :
  1. Number of adverse events associated with ingestion of E. coli Nissle 1917 [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276508


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Elizabeth Lucas
Investigators
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Principal Investigator: Venkata R Jayanthi, MD Nationwide Children's Hospital
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Responsible Party: Elizabeth Lucas, Principal Invesgator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02276508    
Other Study ID Numbers: IRB14-00586
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Urinary Tract Infections
Infection
Urologic Diseases