Bacteriuria Eradication Through Probiotics (BERP)

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ClinicalTrials.gov Identifier: NCT00717600

Recruitment Status : Unknown

Verified July 2008 by Baylor College of Medicine.
Recruitment status was: Enrolling by invitation

First Posted : July 17, 2008

Last Update Posted : July 17, 2008

Sponsor:

Collaborators:

Texas Children's Hospital

Chr Hansen

Lawson Health Research Institute

Information provided by:

Baylor College of Medicine

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Bacteriuria	Dietary Supplement: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1	Phase 1

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


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	10 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Bacteriuria Eradication Through Probiotics
Study Start Date :	January 2008
Estimated Primary Completion Date :	September 2008
Estimated Study Completion Date :	September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Lactobacillus

Genetic and Rare Diseases Information Center resources: Spina Bifida Myelomeningocele

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 Oral probiotics	Dietary Supplement: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 2x10^9 cfu of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 administered daily via a single orally ingested freeze-dried capsule. Other Name: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 (Urex cap-5 from CHR. Hansen), batch 2750558

Outcome Measures

Primary Outcome Measures :

bacteriuria [ Time Frame: 3 months ]

Secondary Outcome Measures :

urinary tract infections [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 18 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
pregnancy
chronic indwelling catheters in the bladder
any urinary diversion or bladder augmentation.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717600

Locations


United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Texas Children's Hospital

Chr Hansen

Lawson Health Research Institute

Investigators


Principal Investigator:	Eric A Jones, M.D.	Texas Children's Hospital, Baylor College of Medicine

More Information


Responsible Party:	Eric A. Jones, Texas Children's Hospital
ClinicalTrials.gov Identifier:	NCT00717600 History of Changes
Other Study ID Numbers:	H-21679
First Posted:	July 17, 2008 Key Record Dates
Last Update Posted:	July 17, 2008
Last Verified:	July 2008

Keywords provided by Baylor College of Medicine:


bacteriuria urinary tract infection probiotics lactobacillus vagina	bladder neurogenic bladder spina bifida myelomeningocele neuropathic bladder

Additional relevant MeSH terms:


Bacteriuria Urinary Tract Infections Infection Urologic Diseases

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