Probiotics for Girls With Recurring Urinary Tract Infections

NCT00789464 | Withdrawn Phase 2

• 1 other identifier: H-23187
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Urinary Tract Infection; Probiotics; Dietary Supplements; Bacteriuria

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms.

  1 year

Study Arms (2)

ARM A

OTHER

Probiotics drops plus placebo elixir

Dietary Supplement: Lactobacillus reuteri DSM 17938

ARM B

OTHER

TMP/SMZ elixir plus placebo drops

Drug: trimethoprim/sulfamethoxazole

Interventions

Lactobacillus reuteri DSM 17938 DIETARY_SUPPLEMENT

DSM 17938 drops (10\^8 cfu/dose of 5 drops) + placebo elixir once daily for 1 year.

ARM A

trimethoprim/sulfamethoxazole DRUG

Trimethoprim/sulfamethoxazole elixir (TMP/SMZ) (2 mg/kg), a standardized oral antibiotic prophylaxis, plus placebo capsule once daily for 1 year.

Also known as: TMP/SMZ, Bactrim, Septra

ARM B

Eligibility Criteria

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

You may qualify if:

• Girls age 1 through age 17 years of age
• Must have had at least 3 symptomatic urinary tract infections in the year before the start of the prophylaxis.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Bacteriuria

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• David R. Roth, 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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, TCH Urology

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 11, 2008
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

US (1)