High Dosage Group for Spinal Cord Injury

MedStar National Rehabilitation Hospital, Washington, United States
Spinal Cord Injury+1 More ConditionsCulturelle 10 Billion CFU Capsule (2 doses) - Drug
Eligibility
18+
All Sexes

Study Summary

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

Eligible Conditions
  • Spinal Cord Injury
  • Neurogenic Bladder

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

10 Primary · 0 Secondary · Reporting Duration: (SA2) 24-48 hours after intervention completion

Hour 48
Change in Cultivable Bacteria
Change in Urine NGAL
Change in Urine Nitrite
Change in Urine microbiome composition
Change in Urine white blood cell count
Hour 48
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
Day 1
International SCI Core Data Set
International SCI Lower Urinary Tract Function Basic Data Set
NINDS Medical History CDE
NINDS Prior and Concomitant Medications CDE

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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2
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2 Treatment Groups

High Dosage Group
1 of 2
Low Dosage Group
1 of 2

Experimental Treatment

182 Total Participants · 2 Treatment Groups

Primary Treatment: High Dosage Group · No Placebo Group · Phase 2

High Dosage Group
Drug
Experimental Group · 1 Intervention: Culturelle 10 Billion CFU Capsule (4 doses) · Intervention Types: Drug
Low Dosage Group
Drug
Experimental Group · 1 Intervention: Culturelle 10 Billion CFU Capsule (2 doses) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: (sa2) 24-48 hours after intervention completion

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor
178 Previous Clinical Trials
134,048 Total Patients Enrolled
Children's National Research InstituteOTHER
195 Previous Clinical Trials
206,296 Total Patients Enrolled
Suzanne Groah, MD, MSPHPrincipal InvestigatorMedStar National Rehabilitation Hospital
2 Previous Clinical Trials
302 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to use a catheter to empty your bladder.
You have had a spinal cord injury for at least one year.
You have a medical condition called neurogenic bladder.
You live in your own home or apartment.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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