Bacteriuria Eradication Through Probiotics (BERP)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Texas Children's Hospital
Chr Hansen A/S
Lawson Health Research Institute
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00717600
First received: July 16, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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 Intervention Phase
Bacteriuria
Dietary Supplement: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bacteriuria Eradication Through Probiotics

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • bacteriuria [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • urinary tract infections [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: January 2008
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 A/S
Lawson Health Research Institute
Investigators
Principal Investigator: Eric A Jones, M.D. Texas Children's Hospital, Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Eric A. Jones, Texas Children's Hospital
ClinicalTrials.gov Identifier: NCT00717600     History of Changes
Other Study ID Numbers: H-21679
Study First Received: July 16, 2008
Last Updated: July 16, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014