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Withdrawn by PI
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A | Other | Probiotics drops plus placebo elixir |
|
| ARM B | Other | TMP/SMZ elixir plus placebo drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri DSM 17938 | Dietary Supplement | DSM 17938 drops (10^8 cfu/dose of 5 drops) + placebo elixir once daily for 1 year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R. Roth, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D001437 | Bacteriuria |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
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| trimethoprim/sulfamethoxazole | Drug | Trimethoprim/sulfamethoxazole elixir (TMP/SMZ) (2 mg/kg), a standardized oral antibiotic prophylaxis, plus placebo capsule once daily for 1 year. |
|
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009930 |
| Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |