Bleach and Urine Color in UC Patients Using 5ASA

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effect on urine color by adding household bleach to fresh urine sample among pediatric UC subjects treated with 5ASA

Detailed Description
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The aim of this study is to evaluate the effect on urine color by adding household bleach to fresh urine sample among pediatric UC subjects treated with 5ASA.

Official Title
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The Effect of Household Bleach on Urine Color Among Pediatric Ulcerative Colitis Patients Treated With 5-aminosalicylic Acid

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Other: Adding household bleach to urine sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. UC patients in remission Exclusion Criteria: Acute UC exacerbation defined as Pediatric ulcerative colitis activity index (PUCAI) ≥10 Any acute or chronic renal disease, either present or past Chronic hypertension, either present or past Regularly receiving other medication that may cause nephrotoxicity - Non-steroidal anti-inflammatory drugs, acetaminophen, anti-epileptics, and antibiotics. Pregnancy

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pediatric UC subjects treated with 5ASA compunds<br>Each subject will provide a fresh urine sample in an empty sterile plastic cup. Urinalysis will be performed to check for macro- or micro-hematuria or signs of infection. We will take 10mL of the urine sample and add 1mL of transparent (colorless) household bleach (≤5% sodium hypochlorite). The color of the urine before and 5 minutes after adding the bleach will be recorded. | Other: Adding household bleach to urine sample<br>* Adding household bleach to urine sample<br>|
| Placebo Comparator: Pediatric UC subjects not treated with 5ASA compunds (any other treatments is allowed)<br>Each subject will provide a fresh urine sample in an empty sterile plastic cup. Urinalysis will be performed to check for macro- or micro-hematuria or signs of infection. We will take 10mL of the urine sample and add 1mL of transparent (colorless) household bleach (≤5% sodium hypochlorite). The color of the urine before and 5 minutes after adding the bleach will be recorded. | Other: Adding household bleach to urine sample<br>* Adding household bleach to urine sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change is urine color | Following the addition of 1mL of 5% household bleach to a 10mL of each subject's urine, we will visually look for color change to red or orange within 5 minutes. Urine changing color to red or orange will be marked as a positive response to the bleach, which would fulfill the primary outcome. | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematuria, Urine, 5-Aminosalycilic acid