Bacteriuria Eradication Through Probiotics

NCT00717600 | Unknown Phase 1 DMC

• 1 other identifier: H-21679
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacteriuria

Keywords

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

Outcome Measures

Primary Outcomes (1)

• bacteriuria

  3 months

Secondary Outcomes (1)

• urinary tract infections

  3 months

Study Arms (1)

1

EXPERIMENTAL

Oral probiotics

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

Interventions

Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 DIETARY_SUPPLEMENT

2x10\^9 cfu of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 administered daily via a single orally ingested freeze-dried capsule.

Also known as: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 (Urex cap-5 from CHR. Hansen), batch 2750558

1

Eligibility Criteria

• Age: Up to 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Chr Hansen: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Bacteriuria; Urinary Tract Infections; Urinary Bladder, Neurogenic; Spinal Dysraphism; Meningomyelocele

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Eric A Jones, M.D.

  Texas Children's Hospital, Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 17, 2008
• Study Start: January 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 17, 2008

Record last verified: 2008-07

Locations

US (1)