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Probiotic

Probiotics for Urinary Symptoms After Spinal Cord Injury

Phase 2

Recruiting

Led By Suzanne Groah, MD, MSPH

Research Sponsored by Medstar Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Neurogenic bladder

Utilizing intermittent catheterization for bladder management

Timeline

Screening 3 weeks

Treatment Varies

Follow Up (sa2) 24-48 hours after intervention completion

Awards & highlights

Study Summary

This trial will help determine how effective a certain probiotic is in reducing urinary symptoms.

Who is the study for?

This trial is for premenopausal women not currently menstruating, with spinal cord injury (SCI) for at least a year, who have neurogenic bladder and use intermittent catheterization. They should live in the community and not be part of another study or have used antibiotics recently.Check my eligibility

What is being tested?

The trial tests two doses of Culturelle capsules to see which one might reduce urinary symptoms after SCI. It aims to understand what changes mean better health regarding urinary issues, inflammation, bacteria presence, and overall urine ecosystem.See study design

What are the potential side effects?

While specific side effects are not listed here, Lactobacillus treatments like Culturelle can sometimes cause digestive discomfort or mild infections due to bacterial imbalance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a condition where my bladder doesn't empty properly due to nerve problems.

Select...

I use a catheter sometimes to help empty my bladder.

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I am a premenopausal woman not having periods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ (sa2) 24-48 hours after intervention completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~(sa2) 24-48 hours after intervention completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and (sa2) 24-48 hours after intervention completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Cultivable Bacteria

Change in Urine NGAL

Change in Urine Nitrite

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low Dosage GroupExperimental Treatment1 Intervention

For the LGG® instillation, participants will be instructed to mix the contents of 1 LGG capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG mixture into a 60cc syringe and instill via the intermitent catheter. Participants will receive 2 LGG capsules and will repeat this process the following day ("Low" dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (2 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining kits (including LGG®). Participants will be instructed to complete the USQNB-IDC weekly until study completion.

Group II: High Dosage GroupExperimental Treatment1 Intervention

For the LGG® instillation, participants will be instructed to mix the contents of 1 LGG capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG mixture into a 60cc syringe and instill via the intermittent catheter. Participants will receive 4 LGG capsules and will repeat this process the following day twice for a total of four doses ("High" dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (4 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining kits (including LGG®). Participants will be instructed to complete the USQNB-IDC weekly until study completion.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor

189 Previous Clinical Trials

115,391 Total Patients Enrolled

Children's National Research InstituteOTHER

211 Previous Clinical Trials

207,975 Total Patients Enrolled

Suzanne Groah, MD, MSPHPrincipal InvestigatorMedStar National Rehabilitation Hospital

2 Previous Clinical Trials

302 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is High Dosage Group usually employed?

"The High Dosage Group is most often given to patients in order to alleviate vaginal symptoms. However, it can also be used to correct candidiasis of vagina, vaginal flora imbalance, and bacterial vaginosis."

Answered by AI

What adverse effects have been seen in patients who have taken High Dosage Group?

"The High Dosage Group intervention has received a score of 3 for safety. This is because Phase 3 trials have shown some efficacy and there is supporting safety data from multiple rounds of trials."

Answered by AI

Could you tell us about any other research conducted with High Dosage Group?

"High Dosage Group is being researched in 5 different clinical trials, with 1 of those trials in Phase 3. The majority of research is being conducted in Shenzhen, Guangdong; however, there are a total of 14 locations running clinical trials related to High Dosage Group."

Answered by AI

Are participants being recruited for this research at this time?

"That is correct. The information available on clinicaltrials.gov suggests that this study is presently looking for 182 patients from 1 location. The data also shows that the study was first posted on 5/20/2020 and was last edited on 9/23/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury

2020. "Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04373512.

All > Spinal Cord Injury > Spinal Cord