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

NCT02748356 | Completed Phase 2 Results DMC

• 1 other identifier: 5753
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

As a collaborative effort between MedStar National Rehabilitation Hospital (NRH), Children's National Medical Center (CNMC) Department of Urology, Children's Research Institute (CRI) Center for Genetic Medicine Research, Georgetown University, and MedStar Georgetown University Hospital, the overall objective of this study is to develop, validate, and assess a patient-initiated, probiotic-based, selfmanagement 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

Outcome Measures

Primary Outcomes (1)

• Lactobacillus Safety

  Total Adverse Events (AE + Serious AE) per participants

  months 1-18 of study

Secondary Outcomes (1)

• Lactobacillus Tolerability

  months 7-18

Study Arms (1)

Individuals with Spina Bifida

EXPERIMENTAL

Lactobacillus rhamnosus GG

Drug: Lactobacillus

Interventions

Lactobacillus DRUG

Eligible patients will undergo 1 Lactobacillus pediatric dose (Culturelle GG 10 Billion live organisms) instillation by study personnel at the study site. For the intravesicular Lactobacillus instillation, the contents of 1 Lactobacillus capsule will be mixed into sterile 0.9% saline using an age-based estimate of bladder capacity. Similar to adults, this bladder instillation will represent 10% of the estimated maximum bladder volume based on age.

Also known as: Culturelle

Individuals with Spina Bifida

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥6 years, and
• Spina bifida and neuropathic bladder, as determined by the attending physician, and
• Utilization of intermittent catheterization for bladder management, and
• History of 2 or more urinary tract infections (UTIs) in the past year, and
• Community dwelling.

You may not qualify if:

• Has a known genitourinary pathology beyond neuropathic bladder (e.g. vesicoureteral reflux, bladder stones, kidney stones, etc), and/or
• Uses prophylactic antibiotics, and/or
• Uses intravesicular agents to reduce UTI (e.g. gentamycin), and/or
• Has psychologic or psychiatric conditions influencing the ability to follow instructions, and/or
• Participates in another study in which results would be confounded, and/or
• Is pregnant or breastfeeding, and/or
• Has a history of acquired or genetic immunodeficiencies, or active, acute or chronic serious infections (e.g. viral hepatitides, HIV/AIDs), and/or
• Has cancer or an autoimmune disorder, and/or
• Has a serious allergy to any component or excipients in the live bacterial combination product, and/or
• Has had a change in neurologic status in the previous 2 weeks, and/or
• Has taken antibiotic for any reason in the previous 2 weeks, and/or
• Has a history of sensitivity or allergy to ampicillin or tetracycline, and/or
• Has a 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
• Children's National Research Institute: collaborator
• Georgetown University: 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

Interventions

Lacteol

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

• Hans Pohl, MD

  Children's National Research Institute

  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 21, 2018
• Study Completion: December 31, 2018
• Last Updated: April 24, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-04

Locations

US (2)