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

Clalit Health Services

Status: Active, not recruiting

Conditions: Ulcerative Colitis

Treatments: Other: Adding household bleach to urine sample

Study type: Interventional

Funder types: Other

Identifiers

NCT06013696

MMC-22-198

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 4 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. UC patients in remission

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Pediatric UC subjects treated with 5ASA compunds

Active Comparator group

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.

Treatment:

Other: Adding household bleach to urine sample

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

Placebo Comparator group

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.

Treatment:

Other: Adding household bleach to urine sample