Open Label Trial of Nissle 1917
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|ClinicalTrials.gov Identifier: NCT02276508|
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : February 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections||Drug: E. coli Nissle 1917||Phase 1|
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.
20 adult (>21 years of age) healthy volunteers
- 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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|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|
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
- Number of adverse events associated with ingestion of E. coli Nissle 1917 [ Time Frame: 30 days ]
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
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Venkata R Jayanthi, MD||Nationwide Children's Hospital|