Impact of Probiotics on Urinary Symptoms in Spinal Cord Injury SCI and SB

NCT02748317 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2014-211
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief Summary

As a collaborative effort between MedStar National Rehabilitation Hospital (NRH)/MedStar Health Research Institute (MHRI), Children's National Medical Center (CNMC) Department of Urology, Children's Research Institute (CRI) Center for Genetic Medicine Research, and Georgetown University Medical Center, the overall objective of this study is to develop, validate, and assess a patient-initiated, probiotics-based, self management protocol that is initiated at the time of urinary symptoms. The self-management protocol will allow patients to manage urinary symptoms and avoid potentially unnecessary antibiotic use, and provide a readily-available means of maintaining health, function, and independence throughout the lifespan.

Conditions

Lower Urinary Tract Symptoms

Keywords

Spina Bifida; Spinal Cord Injury; Lower Urinary Tract Symptoms; Probiotics; Intermittent Catheterization

Outcome Measures

Primary Outcomes (1)

• Lactobacillus Safety

  Total Adverse Events (AE + Serious AE) per participant .

  months 1-18 of study

Secondary Outcomes (1)

• Lactobacillus Tolerability

  Months 7-18

Study Arms (1)

Adults with Spinal Cord Injury

EXPERIMENTAL

Lactobacillus rhamnosus GG

Drug: Lactobacillus rhamnosus GG

Interventions

Lactobacillus rhamnosus GG DRUG

For the intravesicular Lactobacillus instillation, participants will be instructed to mix the contents of 1 Lactobacillus capsule into 45 cc sterile 0.9% saline.5,6 After mixing, participants will draw up the 45 cc of the liquid Lactobacillus mixture into a 60cc catheter tip syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 10 Lactobacillus GG tabs at the beginning of treatment phase. At the end of each month, the coordinator or RA will ask how many remaining tablets the participant has, and if needed dispense the next supply of 10 tablets Participants will be instructed to complete the USQ-NB weekly.

Also known as: Culturelle

Adults with Spinal Cord Injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 years
• SCI, SB or MS at least 1-year duration
• Neuropathic bladder, as determined by the attending physician
• Utilizing intermittent catheterization for bladder management
• A history of 2 or more UTIs in the past year
• Community dwelling.

You may not qualify if:

• Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.)
• Use of prophylactic antibiotics
• Instillation of intravesicular agents to reduce UTI (i.e., gentamycin)
• Psychologic or psychiatric conditions influencing the ability to follow instructions
• Participation in another study in which results would be confounded
• Pregnant or breastfeeding
• Individuals with a history of acquired or genetic immunodeficiencies; active, acute or chronic serious infections (i.g., viral hepatitides, HIV/AIDs)
• Individuals with cancer/autoimmune disorders
• Serious allergy to any component or excipients in the live bacterial combination product
• No change in neurologic status in the previous 2 weeks
• Taken antibiotic for any reason in the previous 2 weeks
• Any patient with history of sensitivity or allergy to ampicillin or tetracycline
• Current urinary tract infection or urinary tract infection within the previous 2 weeks (as defined by Infectious Diseases Society of America CAUTI Guidelines, 2010).

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Georgetown University: collaborator
• Children's National Research Institute: collaborator

Study Sites (2)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Spinal Dysraphism; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Inger Ljungberg
• Organization: MedStar Health Research Institute

inger.h.ljungberg@medstar.net

202-877-1694

Study Officials

• Suzanne L Groah, MD, MSPH

  MedStar National Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: April 22, 2016
• Study Start: January 1, 2016
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)