CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 7 enrolled
Drug / intervention
Lactobacillusdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02748356
NCT02748356Phase 2Completed
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The Impact of Self-Management With Probiotics on Urinary Symptoms and the Urine Microbiome in Individuals With Spinal Cord Injury (SCI) and Spina Bifida (SB)

Medstar Health Research Institute·interventional·Posted Apr 22, 2016·Updated Apr 24, 2020

In Brief

A Phase 2 clinical trial evaluating Lactobacillus for Lower Urinary Tract Symptoms. Completed, enrolled 7 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLower Urinary Tract Symptoms
CountriesUnited States
CollaboratorsPatient-Centered Outcomes Research Institute, Children's National Research Institute, Georgetown University

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 22, 2016
Enrollment StartJan 1, 2016
Primary CompletionOct 21, 2018
Study CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.2 years ago

Interventions

Lactobacillusdrug

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.