BacteriuriaPhase 1BERPNCT00717600
Bacteriuria Eradication Through Probiotics
A Phase 1 study testing Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 in people with Bacteriuria, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Many children who catheterize their bladders because of spina bifida or other neurologic disorders have bacteriuria. This can lead to urinary tract infections by bacteria from the gut which colonize the vagina and are carried into the bladder during catheter passage. Read more about this study
- Who is it for?
- Ages Up to 18 years, women only
- Conditions the study is for
- Bacteriuria
- What is being tested?
- Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Sep 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Eligible subjects are girls (age 3 months to 18 years) with spina bifida as a sole urologic diagnosis
- perform clean intermittent catheterization because of neurogenic bladder.
- Secondary vesicoureteral reflux is permissible.
- Patients with appendicovesicostomies and no other forms of urinary diversion are permitted.
Who cannot join
- Patients will be excluded if they are taking antibiotics
- immunosuppressed, i.e., transplant recipients or children with congenital immunodeficiencies
- poorly controlled diabetes
- untreated HIV infection
- immunosuppression from corticosteroids
- malnutrition
Show all 9Show fewer
- pregnancy
- chronic indwelling catheters in the bladder
- any urinary diversion or bladder augmentation.
Trial locations and contacts
1 site in 1 country.
About this study
Many children who catheterize their bladders because of spina bifida or other neurologic disorders have bacteriuria. This can lead to urinary tract infections by bacteria from the gut which colonize the vagina and are carried into the bladder during catheter passage. We seek to test whether oral administration of probiotic bacteria can "displace" these vagina-derived uropathogens and reduce or prevent bacteriuria in girls with spina bifida who empty their bladders through catheterization.
Read the 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 urinary tract infections are common. Furthermore, this approach carries the potential for deleterious side effects, and may promote the development of antibiotic-resistant bacteria.
Urinary tract infection in girls occurs 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 L. 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 Lactobacillus GG drinks had fewer episodes of UTI compared to those women not receiving probiotics. A placebo-controlled study in premature infants also used L. rhamnosus 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 patients 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.
Our objective is to determine whether over the course of 3 months, probiotics can reduce preexisting or new bacteriuria in girls with spina bifida who perform clean intermittent catheterization for bladder emptying. We will also attempt to ascertain whether changes in bacteriuria are associated with vaginal colonization by the administered probiotics.
- Conditions
- Bacteriuria
- Being tested
- Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1
- Keywords
- bacteriuria, urinary tract infection, probiotics, lactobacillus, vagina, bladder, neurogenic bladder, spina bifida, myelomeningocele, neuropathic bladder
- Medical subject headings
- Bacteriuria, Urinary Tract Infections, Urinary Bladder, Neurogenic, Spinal Dysraphism, Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1Dietary supplement
Also called Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 (Urex cap-5 from CHR. Hansen), batch 2750558
2x10^9 cfu of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 administered daily via a single orally ingested freeze-dried capsule.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral probiotics Receives: Dietary Supplement: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacteriuria
Measured: 3 months
Secondary outcomes (1)
urinary tract infections
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2008 (estimated)
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteriuriaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Chr Hansen, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Eric A Jones, M.D., Principal investigator, Texas Children's Hospital, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717600
- Sponsor's protocol ID
- H-21679
- Acronym
- BERP
- Status last verified
- Jul 2008
- First submitted
- 16 Jul 2008
- Last updated
- 17 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteriuria Eradication Through Probiotics
- ClinicalTrials.gov ID
- NCT00717600
- Acronym / sponsor ID
- BERP / H-21679
- Conditions
- Bacteriuria
- Keywords
- bacteriuria, urinary tract infection, probiotics, lactobacillus, vagina, bladder, neurogenic bladder, spina bifida
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Chr Hansen, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Study start
- Jan 2008
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Sep 2008 (estimated)
- First posted
- 17 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many children who catheterize their bladders because of spina bifida or other neurologic disorders have bacteriuria. This can lead to urinary tract infections by bacteria from the gut which colonize the vagina and are carried into the bladder during catheter passage. We seek to test whether oral administration of probiotic bacteria can "displace" these vagina-derived uropathogens and reduce or prevent bacteriuria in girls with spina bifida who empty their bladders through catheterization.
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 urinary tract infections are common. Furthermore, this approach carries the potential for deleterious side effects, and may promote the development of antibiotic-resistant bacteria.
Urinary tract infection in girls occurs 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 L. 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 Lactobacillus GG drinks had fewer episodes of UTI compared to those women not receiving probiotics. A placebo-controlled study in premature infants also used L. rhamnosus 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 patients 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.
Our objective is to determine whether over the course of 3 months, probiotics can reduce preexisting or new bacteriuria in girls with spina bifida who perform clean intermittent catheterization for bladder emptying. We will also attempt to ascertain whether changes in bacteriuria are associated with vaginal colonization by the administered probiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1Oral probiotics |
Who may qualify
- Ages
- Up to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Eligible subjects are girls (age 3 months to 18 years) with spina bifida as a sole urologic diagnosis
- perform clean intermittent catheterization because of neurogenic bladder.
- Secondary vesicoureteral reflux is permissible.
- Patients with appendicovesicostomies and no other forms of urinary diversion are permitted.
Key exclusion criteria (9 listed)
- Patients will be excluded if they are taking antibiotics
- immunosuppressed, i.e., transplant recipients or children with congenital immunodeficiencies
- poorly controlled diabetes
- untreated HIV infection
- immunosuppression from corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1Also: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 (Urex cap-5 from CHR. Hansen), batch 27505582x10^9 cfu of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 administered daily via a single orally ingested freeze-dried capsule. | Dietary supplement | 1 |
Primary outcome
bacteriuria
Time frame: 3 months
1 secondary outcome
urinary tract infections
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric A Jones, M.D. principal investigator
Texas Children's Hospital, Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 in people with Bacteriuria, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacteriuria (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2008.