Bleach and Urine Color in UC Patients Using 5ASA

Not Applicable

Active, not recruiting

• Conditions: Ulcerative Colitis
• Interventions: Other: Adding household bleach to urine sample

• Registration Number: NCT06013696
• Lead Sponsor: Meir Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-07-16
• Status Verified: 2023-08
• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Study First Posted: 2023-08-28
• Last Update Posted: 2023-08-28
• Primary Completion: 2024-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. UC patients in remission

Read More

Exclusion Criteria

1. Acute UC exacerbation defined as Pediatric ulcerative colitis activity index (PUCAI) ≥10
2. Any acute or chronic renal disease, either present or past
3. Chronic hypertension, either present or past
4. Regularly receiving other medication that may cause nephrotoxicity - Non-steroidal anti-inflammatory drugs, acetaminophen, anti-epileptics, and antibiotics.
5. Pregnancy

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pediatric UC subjects not treated with 5ASA compunds (any other treatments is allowed)	Adding household bleach to urine sample	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.
Pediatric UC subjects treated with 5ASA compunds	Adding household bleach to urine sample	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.

Primary Outcome Measures

Name	Time	Method
Change is urine color	5 minutes	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.

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel