Probiotics in Girls With Spina Bifida

NCT00767988 | Withdrawn Phase 2

• 1 other identifier: H-23245
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Urinary Tract Infection

Keywords

Probiotics; Spina Bifida; Dietary Supplements; Bacteriuria; Urinary Tract Infection (UTI)

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the rates of bacteriuria among patients in the placebo versus probiotics arms.

  This will be calculated at the end of the 6 months of administering probiotics/placebo.

Secondary Outcomes (1)

• 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.

  6 months

Study Arms (2)

A

ACTIVE COMPARATOR

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)

B

PLACEBO COMPARATOR

Capsule 1:1

Other: Placebo

Interventions

Urex-cap-5 (2x10^9 cfu each of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1) DIETARY_SUPPLEMENT

Capsules once daily at approximately the same time each day for 6 months.

A

Placebo OTHER

Capsule once daily at approximately the same time each day for 6 months.

B

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Girls
• Age 3 months to 18 years
• Spina bifida as a sole urologic diagnosis
• Informed consent and assent (7 years of age and older)

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Shriners Hospitals for Children: collaborator

Study Sites (2)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Shriner's Childrens Hospital Houston

Houston, Texas, 77077, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Spinal Dysraphism; Bacteriuria

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Eric A. Jones, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 7, 2008
• Last Updated: September 15, 2015

Record last verified: 2015-09

Locations

US (2)