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

NCT02748356 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-04-24

Study results available
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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

Interventions

DRUG

Lactobacillus

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.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Children's National Research Institute

    collaborator OTHER

  • Georgetown University

    collaborator OTHER

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Hans Pohl, MD · Children's National Research Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-10-21
Completion
2018-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02748356 on ClinicalTrials.gov