Open Label Trial of Nissle 1917

NCT02276508 | Completed Phase 1 DMC

• 1 other identifier: IRB14-00586
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

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

  30 days

Study Arms (1)

Probiotic

EXPERIMENTAL

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

E. coli Nissle 1917 DRUG

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

Also known as: Mutaflor

Probiotic

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult volunteer of age 21 years or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elizabeth Lucas: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Venkata R Jayanthi, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Invesgator

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 28, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: February 18, 2015

Record last verified: 2015-02

Locations

US (1)