Trial Outcomes & Findings for Impact of Probiotics on Urinary Symptoms in Spinal Cord Injury SCI and SB (NCT NCT02748317)

NCT ID: NCT02748317

Last Updated: 2020-05-12

Results Overview

Total Adverse Events (AE + Serious AE) per participant .

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 96 participants
• Primary outcome timeframe: months 1-18 of study
• Results posted on: 2020-05-12

Participant Flow

Participants were recruited nationwide between Jan 20, 2016, and May 31, 2017

Participant milestones

Measure	Adults With Spinal Cord Injury, Spina Bifida or MS Lactobacillus instillation: During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.
Overall Study STARTED	96
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Measure	Adults With Spinal Cord Injury, Spina Bifida or MS Lactobacillus instillation: During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.
Overall Study Withdrawal by Subject	14
Overall Study Lost to Follow-up	8
Overall Study Death	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Adults With Spinal Cord Injury, Spina Bifida or MS n=96 Participants Lactobacillus instillation During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	89 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	43.7 years n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants
Race (NIH/OMB) White	70 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	96 participants n=5 Participants

PRIMARY outcome

Timeframe: months 1-18 of study

Population: All adult study participants

Total Adverse Events (AE + Serious AE) per participant .

Outcome measures

Measure

Adults With Spinal Cord Injury, Spina Bifida or MS n=96 Participants Lactobacillus instillation During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.

Lactobacillus Safety

.594 Adverse Events Standard Deviation 1.09

SECONDARY outcome

Timeframe: Months 7-18

Population: 50 adult participants instilled Lactobacillus at least once

This is a one-item satisfaction rating. "While thinking only about the preceding 6-month time period: "can you estimate, using a scale from 0 to 100%, whether or not you would seek out this intervention and pay for it yourself if insurance did not pay for it?" Participants indicated their answer by moving a "slider" with three anchors: 0%=Would absolutely never do this; 50%=Might do this; 100%= Would absolutely do this. If a participant is less satisfied, their rating will be lower, and if they are more satisfied, the rating would be higher, but the item did not have options for "better" or "worse". This is not a published scale, we included this item in our general data collection.

Ratings averaged over final 12 months of study (Satisfaction question was answered by study participants at 3 time points; 6 months, 12 months and 18 months)

Outcome measures

Measure

Adults With Spinal Cord Injury, Spina Bifida or MS n=50 Participants Lactobacillus instillation During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.

Lactobacillus Tolerability

60.6 units on a scale Standard Deviation 27.58

Adverse Events

Adults With Spinal Cord Injury, Spina Bifida or MS

Serious events: 32 serious events

Other events: 11 other events

Deaths: 1 deaths

Serious adverse events

Measure	Adults With Spinal Cord Injury, Spina Bifida or MS n=96 participants at risk Lactobacillus instillation During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.
Cardiac disorders Believed heart attack	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Cardiac disorders Sepsis/ cardiomyopathy	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Cardiac disorders Low blood pressure	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Gastrointestinal disorders C-diff	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Infections and infestations Infection in Abcess	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Infections and infestations Osteomyelitis	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Musculoskeletal and connective tissue disorders Hip Infection	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Musculoskeletal and connective tissue disorders Acute arthritis	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Musculoskeletal and connective tissue disorders Fractures	2.1% 2/96 • Number of events 2 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Nervous system disorders Transient ischemic attack	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Psychiatric disorders Mental health issues	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Renal and urinary disorders Urinary tract infection	9.4% 9/96 • Number of events 16 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Renal and urinary disorders Kidney infection	2.1% 2/96 • Number of events 2 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Renal and urinary disorders Prostate infection	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Respiratory, thoracic and mediastinal disorders Pneumonia	2.1% 2/96 • Number of events 3 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Respiratory, thoracic and mediastinal disorders Respiratory infection	2.1% 2/96 • Number of events 2 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Skin and subcutaneous tissue disorders Pressure Ulcer/ Wound	2.1% 2/96 • Number of events 2 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Surgical and medical procedures Surgery	4.2% 4/96 • Number of events 5 • Adverse Events were collected on all participants throughout their study participation which was 18 months.

Other adverse events

Measure	Adults With Spinal Cord Injury, Spina Bifida or MS n=96 participants at risk Lactobacillus instillation During intervention phase participants were instructed to instill a Lactobacillus solution via their intermittent catheter when they experienced cloudier or more bad- smelling, stronger, fouler or more pungent than their normal urine. These symptoms had to be experienced in the absence of fever, shaking chills, feeling unclear, foggy or confused, overall sense of discomfort, feeling more tired than usual, side pain in the lower back, tenderness to touch in the side of the low back, blood in urine, abdominal pain below, belly button, increase in muscle tightness or tone, autonomic dysreflexia, sense of unease.
General disorders Physical Discomfort	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Nervous system disorders Migraine	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Renal and urinary disorders Urinary tract infection	6.2% 6/96 • Number of events 7 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Renal and urinary disorders Discomfort Instilling Lactobacillus	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Renal and urinary disorders Low urine PH value	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Social circumstances Accident with urological supplies	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.
Surgical and medical procedures Removal or kidney stones	1.0% 1/96 • Number of events 1 • Adverse Events were collected on all participants throughout their study participation which was 18 months.

Additional Information

Inger Ljungberg

MedStar Health Research Institute

Phone: 202-877-1694

Email: inger.h.ljungberg@medstar.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place