Asableach: Bleach and Urine Color in UC Patients Using 5ASA

Sponsor

Meir Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06013696

Collaborator

(none)

Enrollment

Location

Arms

16.6

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Other: Adding household bleach to urine sample	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 16, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pediatric UC subjects treated with 5ASA compunds 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 Adding household bleach to urine sample
Placebo Comparator: Pediatric UC subjects not treated with 5ASA compunds (any other treatments is allowed) 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 Adding household bleach to urine sample

Arm

Intervention/Treatment

Active Comparator: Pediatric UC subjects treated with 5ASA compunds

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

Adding household bleach to urine sample

Placebo Comparator: Pediatric UC subjects not treated with 5ASA compunds (any other treatments is allowed)

Other: Adding household bleach to urine sample

Adding household bleach to urine sample

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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