Probiotics in Girls With Spina Bifida
Primary Purpose
Urinary Tract Infection
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Urex-cap-5 (2x10^9 cfu each of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infection focused on measuring Probiotics, Spina Bifida, Dietary Supplements, Bacteriuria, Urinary Tract Infection (UTI)
Eligibility Criteria
Inclusion Criteria:
- Girls
- Age 3 months to 18 years
- Spina bifida as a sole urologic diagnosis
- Informed consent and assent (7 years of age and older)
Exclusion Criteria:
- Males
- Females over 18 years and older
- Prophylactic antibiotics
- Immunosuppression from corticosteroids, transplant recipients or children with congenital immunodeficiencies
- Poorly controlled diabetes
- Untreated HIV infection
- Chronic indwelling catheters in the bladder
- Malnourished
- Pregnancy
- Any form of urinary division other than appendicovesicostomies is not permitted
- Bladder augmentation
- Unresolved reflux
Sites / Locations
- Texas Children's Hospital
- Shriner's Childrens Hospital Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A
B
Arm Description
Urex-cap-5 capsules (2x10^9 cfu each of RC-14 and GR-1) 1:1 ratio
Capsule 1:1
Outcomes
Primary Outcome Measures
The primary outcome will be the rates of bacteriuria among patients in the placebo versus probiotics arms.
Secondary Outcome Measures
The secondary outcomes include rates of fungal vaginitis, mean number of urinary tract infections, mean Bristol STool Scale scores, and number of episodes of stool incontinence.
Full Information
NCT ID
NCT00767988
First Posted
October 6, 2008
Last Updated
September 11, 2015
Sponsor
Baylor College of Medicine
Collaborators
Shriners Hospitals for Children
1. Study Identification
Unique Protocol Identification Number
NCT00767988
Brief Title
Probiotics in Girls With Spina Bifida
Official Title
Probiotics Improvement of Gastrointestinal and Genitourinary Health in Girls With Spina Bifida (H-23245)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn by PI
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Baylor College of Medicine
Collaborators
Shriners Hospitals for Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Girls with spina bifida also have bladder problems. This is because they need temporary placement of a tube into the bladder to remove urine. This thin flexible tube is called a catheter. It can increase the risk of having bacteria in the urine. This in turn can lead to urinary tract infection (UTI).
Some girls with spina bifida are given antibiotics. These are medicines used to treat infections caused by bacteria. The medicine is used to prevent UTI. However, long-term treatment with these medicines can have side effects. For example, the bacteria may become resistant to the antibiotics. Also, bacteria in the urine can persist. UTI can still occur in patients on antibiotics.
UTI in girls occurs because bacteria migrate from the rectum to the vagina area. This gives the bacteria access to the bladder. Also, in girls with spina bifida, the access to the bladder is easier because of the catheter.
Probiotics are friendly bacteria. They are available as dietary supplements and as food. They contain helpful bacteria. Yogurt is an example of a food that contains probiotics.
The purpose of this study is to find out, if probiotics taken for 6 months can prevent UTI in girls with spina bifida. We will also try to find out whether changes in urine bacteria are associated with the taking of the probiotics. A vaginal and rectal swab will also be done to find out if taking probiotics has any benefits on preventing bacteria.
Detailed Description
In children with spina bifida and neurogenic bladder dysfunction, the need for intermittent bladder catheterization increases the risk of bacteriuria. In many patients, this leads to a clinically significant urinary tract infection (UTI). Many of these children are placed on long term, low dose antibiotic suppression to prevent recurrent urinary infection. Unfortunately, bacteriuria often persists despite daily antibiotic therapy, and breakthrough UTIs are common. Furthermore, this approach carries the potential for deleterious side effects, and may promote the development of antibiotic-resistant bacteria.
UTI in girls occur when virulent bacteria migrate from the rectum and colonize the vagina and peri-urethral mucosa, thus gaining access to the bladder. In girls with spina bifida, access to the bladder is greatly facilitated by catheter passage. Antibiotic prophylaxis relies on maintaining a low dose of antibiotic in the urinary stream, which decreases peri-urethral colonization, and prevents proliferation of bacteria after they gain access to the bladder. An alternative approach to daily antibiotic prophylaxis is to decrease the risk of urinary colonization with virulent bacteria by supplementing the normal bacteria flora with non-infection causing strains of bacteria.
Probiotics are dietary supplements containing potentially beneficial bacterial strains such as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in several studies over the last 30 years. Studies using Lactobacillus rhamnosus GG, a probiotic introduced in the late 1980s to alleviate diarrhea, have shown promising results when used for UTI prevention. In one study, researchers found that the subjects consuming GG drinks had fewer episodes of UTI compared to those women not receiving probiotics. A placebo-controlled study in premature infants also used GG in an attempt to prevent UTI. The number of urinary infections was reduced but statistically the difference was not significant. Finally, a recent randomized clinical trial demonstrated that the rate of UTI in children taking prophylactic antibiotics was similar to that of patients taking Lactobacillus acidophilus alone. The efficacy of probiotic usage in the spina bifida population has not been reported.
Clinical trials have suggested that oral ingestion of the probiotic strains Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 results in vaginal colonization and prevention of adult UTI, potentially by inhibiting uropathogen ascension from the vagina to the urinary tract.
A total of 60 patients will be enrolled for this pilot study, half of whom will be randomized to receive probiotics and the reminder of which will receive placebo [1:1 ratio; 50% chance of being in each group (A and B)]. Treatment assignment will be double blinded and will last 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
Probiotics, Spina Bifida, Dietary Supplements, Bacteriuria, Urinary Tract Infection (UTI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Urex-cap-5 capsules (2x10^9 cfu each of RC-14 and GR-1) 1:1 ratio
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Capsule 1:1
Intervention Type
Dietary Supplement
Intervention Name(s)
Urex-cap-5 (2x10^9 cfu each of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1)
Intervention Description
Capsules once daily at approximately the same time each day for 6 months.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Capsule once daily at approximately the same time each day for 6 months.
Primary Outcome Measure Information:
Title
The primary outcome will be the rates of bacteriuria among patients in the placebo versus probiotics arms.
Time Frame
This will be calculated at the end of the 6 months of administering probiotics/placebo.
Secondary Outcome Measure Information:
Title
The secondary outcomes include rates of fungal vaginitis, mean number of urinary tract infections, mean Bristol STool Scale scores, and number of episodes of stool incontinence.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Girls
Age 3 months to 18 years
Spina bifida as a sole urologic diagnosis
Informed consent and assent (7 years of age and older)
Exclusion Criteria:
Males
Females over 18 years and older
Prophylactic antibiotics
Immunosuppression from corticosteroids, transplant recipients or children with congenital immunodeficiencies
Poorly controlled diabetes
Untreated HIV infection
Chronic indwelling catheters in the bladder
Malnourished
Pregnancy
Any form of urinary division other than appendicovesicostomies is not permitted
Bladder augmentation
Unresolved reflux
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric A. Jones, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Shriner's Childrens Hospital Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77077
Country
United States
12. IPD Sharing Statement
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Probiotics in Girls With Spina Bifida
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