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Probiotics in Girls With Spina Bifida

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
Texas Children's Hospital
Shriners Hospitals for Children
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00767988
First received: October 6, 2008
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infection
Dietary Supplement: Urex-cap-5 (2x10^9 cfu each of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1)
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Probiotics Improvement of Gastrointestinal and Genitourinary Health in Girls With Spina Bifida (H-23245)

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Urex-cap-5 capsules (2x10^9 cfu each of RC-14 and GR-1) 1:1 ratio
Dietary Supplement: Urex-cap-5 (2x10^9 cfu each of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1)
Capsules once daily at approximately the same time each day for 6 months.
Placebo Comparator: B
Capsule 1:1
Other: Placebo
Capsule once daily at approximately the same time each day for 6 months.

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.

  Eligibility

Ages Eligible for Study:   3 Months to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00767988

Locations
United States, Texas
Shriner's Childrens Hospital Houston
Houston, Texas, United States, 77077
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Texas Children's Hospital
Shriners Hospitals for Children
Investigators
Principal Investigator: Eric A. Jones, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Eric A. Jones, M.D., Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00767988     History of Changes
Other Study ID Numbers: H-23245
Study First Received: October 6, 2008
Last Updated: December 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
Probiotics
Spina Bifida
Dietary Supplements
Bacteriuria
Urinary Tract Infection (UTI)

Additional relevant MeSH terms:
Infection
Spinal Dysraphism
Urinary Tract Infections
Congenital Abnormalities
Nervous System Diseases
Nervous System Malformations
Neural Tube Defects
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014