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BacteriuriaPhase 1BERPNCT00717600

Bacteriuria Eradication Through Probiotics

A Phase 1 study testing Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 in people with Bacteriuria, run by Baylor College of Medicine at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 years, women only
Conditions the study is for
Bacteriuria
What is being tested?
Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Jan 2008to Sep 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • pregnancy
  • chronic indwelling catheters in the bladder
  • any urinary diversion or bladder augmentation.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Texas Children's Hospital

    Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the 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.

Conditions
Bacteriuria
Being tested
Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1
Keywords
bacteriuria, urinary tract infection, probiotics, lactobacillus, vagina, bladder, neurogenic bladder, spina bifida, myelomeningocele, neuropathic bladder
Medical subject headings
Bacteriuria, Urinary Tract Infections, Urinary Bladder, Neurogenic, Spinal Dysraphism, Meningomyelocele

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1Dietary supplement

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

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

Study groups in NCT00717600
Study groupRoleWhat they receive
1ExperimentalOral probiotics
Receives: Dietary Supplement: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. bacteriuria

    Measured: 3 months

Secondary outcomes (1)
  1. urinary tract infections

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionSep 2008 (estimated)
  4. Study completionSep 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00717600
Sponsor's protocol ID
H-21679
Acronym
BERP
Status last verified
Jul 2008
First submitted
16 Jul 2008
Last updated
17 Jul 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 in people with Bacteriuria, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

bacteriuria (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2008.

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