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Bleach and Urine Color in UC Patients Using 5ASA (Asableach)

Primary Purpose

Ulcerative Colitis

Status
Active
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Adding household bleach to urine sample
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ulcerative Colitis focused on measuring Hematuria, Urine, 5-Aminosalycilic acid

Eligibility Criteria

4 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pediatric UC subjects treated with 5ASA compunds

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2023
Last Updated
August 24, 2023
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06013696
Brief Title
Bleach and Urine Color in UC Patients Using 5ASA
Acronym
Asableach
Official Title
The Effect of Household Bleach on Urine Color Among Pediatric Ulcerative Colitis Patients Treated With 5-aminosalicylic Acid
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 16, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Hematuria, Urine, 5-Aminosalycilic acid

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pediatric UC subjects treated with 5ASA compunds
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pediatric UC subjects not treated with 5ASA compunds (any other treatments is allowed)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Adding household bleach to urine sample
Intervention Description
Adding household bleach to urine sample
Primary Outcome Measure Information:
Title
Change is urine color
Description
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.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyal Zifman, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4464402
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
According to instructions from our IRB the study's IPD is not to be shared. Specific requests may be sent after the study's completion and will be considered by the IRB .

Learn more about this trial

Bleach and Urine Color in UC Patients Using 5ASA

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