Recurrent Urinary Tract InfectionPhase 2NCT00789464
Probiotics for Girls With Recurring Urinary Tract Infections
A Phase 2 study testing Lactobacillus reuteri DSM 17938 and trimethoprim/sulfamethoxazole in people with Recurrent Urinary Tract Infection, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Probiotics are dietary supplements containing potentially beneficial bacterial strains such as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in hundreds of studies using adults over the last 30 years. Very few studies have been conducted with children. Read more about this study
- Who is it for?
- Ages 3 months to 17 years, women only
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- Lactobacillus reuteri DSM 17938 and trimethoprim/sulfamethoxazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 3 months to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Girls age 1 through age 17 years of age
- Must have had at least 3 symptomatic UTI, uncomplicated or complicated, in the year preceding study inclusion or already using any form of prophylaxis to prevent recurrences of UTI
- Must have had at least 3 symptomatic urinary tract infections in the year before the start of the prophylaxis.
Who cannot join
- Breastfeeding
- Pregnancy
- Prior adverse reaction to sulfa drugs or sulfamethoxazole/trimethoprim
- Known immunosuppression i.e., transplant recipients or children with congenital immunodeficiencies
- Poorly controlled diabetes
- Untreated HIV infection
Show all 14Show fewer
- Use of high dose corticosteroids for autoimmune diseases or post-organ transplantation. Inhaled corticosteroids or oral steroids for asthma are allowed.
- Malnutrition
- Patients with a history of sulfamethoxazole/trimethoprim-resistant UTI will be excluded from the study
- Patients with renal insufficiency, liver insufficiency, or cardiopulmonary disease requiring medication will be excluded from the study
- Patients with known anemia will be excluded from the study
- Patients taking medications that may interact with sulfamethoxazole/trimethoprim will be excluded from the study
- Patients taking other probiotics will be excluded from the study
- Patients already taking prophylactic antibiotics will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: H-23187: Probiotic Prophylaxis Against Recurrent Pediatric Urinary Tract Infection
Probiotics are dietary supplements containing potentially beneficial bacterial strains such as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in hundreds of studies using adults over the last 30 years. Very few studies have been conducted with children. 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.
This study will randomize girls to ARM A (probiotics + placebo) and ARM B (antibiotics + placebo) to determine if UTIs are decreased when the probiotics are given.
- Conditions
- Recurrent Urinary Tract Infection
- Being tested
- Lactobacillus reuteri DSM 17938, trimethoprim/sulfamethoxazole
- Keywords
- Urinary Tract Infection, Probiotics, Dietary Supplements, Bacteriuria
- Medical subject headings
- Urinary Tract Infections, Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri DSM 17938Dietary supplement
DSM 17938 drops (10^8 cfu/dose of 5 drops) + placebo elixir once daily for 1 year.
trimethoprim/sulfamethoxazoleDrug
Also called TMP/SMZ, Bactrim, Septra
Trimethoprim/sulfamethoxazole elixir (TMP/SMZ) (2 mg/kg), a standardized oral antibiotic prophylaxis, plus placebo capsule once daily for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Other | Probiotics drops plus placebo elixir Receives: Dietary Supplement: Lactobacillus reuteri DSM 17938 |
| ARM B | Other | TMP/SMZ elixir plus placebo drops Receives: Drug: trimethoprim/sulfamethoxazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
Why it stopped: Withdrawn by PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Roth, Baylor College of Medicine
- Investigators
- David R. Roth, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789464
- Sponsor's protocol ID
- H-23187
- Status last verified
- Aug 2020
- First submitted
- 10 Nov 2008
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H-23187: Probiotic Prophylaxis Against Recurrent Pediatric Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT00789464
- Acronym / sponsor ID
- H-23187
- Conditions
- Recurrent Urinary Tract Infection
- Keywords
- Urinary Tract Infection, Probiotics, Dietary Supplements, Bacteriuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn by PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- First posted
- 11 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Probiotics are dietary supplements containing potentially beneficial bacterial strains such as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in hundreds of studies using adults over the last 30 years. Very few studies have been conducted with children. 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.
This study will randomize girls to ARM A (probiotics + placebo) and ARM B (antibiotics + placebo) to determine if UTIs are decreased when the probiotics are given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A | Other | Dietary Supplement: Lactobacillus reuteri DSM 17938Probiotics drops plus placebo elixir |
| ARM B | Other | Drug: trimethoprim/sulfamethoxazoleTMP/SMZ elixir plus placebo drops |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Girls age 1 through age 17 years of age
- Must have had at least 3 symptomatic UTI, uncomplicated or complicated, in the year preceding study inclusion or already using any form of prophylaxis to prevent recurrences of UTI
- Must have had at least 3 symptomatic urinary tract infections in the year before the start of the prophylaxis.
Key exclusion criteria (14 listed)
- Breastfeeding
- Pregnancy
- Prior adverse reaction to sulfa drugs or sulfamethoxazole/trimethoprim
- Known immunosuppression i.e., transplant recipients or children with congenital immunodeficiencies
- Poorly controlled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus reuteri DSM 17938DSM 17938 drops (10^8 cfu/dose of 5 drops) + placebo elixir once daily for 1 year. | Dietary supplement | ARM A |
| trimethoprim/sulfamethoxazoleAlso: TMP/SMZ, Bactrim, SeptraTrimethoprim/sulfamethoxazole elixir (TMP/SMZ) (2 mg/kg), a standardized oral antibiotic prophylaxis, plus placebo capsule once daily for 1 year. | Drug | ARM B |
Primary outcome
The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R. Roth, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactobacillus reuteri DSM 17938 and trimethoprim/sulfamethoxazole in people with Recurrent Urinary Tract Infection, 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 3 inclusion and 14 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: withdrawn, as of the sponsor's last update on 18 Aug 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms. (time frame: 1 year). 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 18 Aug 2020.