Bleach and Urine Color in UC Patients Using 5ASA

NCT06013696 | Unknown

• 1 other identifier: MMC-22-198
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Ulcerative Colitis

Keywords

Hematuria; Urine; 5-Aminosalycilic acid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pediatric UC subjects treated with 5ASA compunds

ACTIVE COMPARATOR

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

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

PLACEBO COMPARATOR

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

Interventions

Adding household bleach to urine sample OTHER

Adding household bleach to urine sample

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

Eligibility Criteria

• Age: 4 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. UC patients in remission

You may not qualify if:

• 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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, 4464402, Israel

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Hematuria

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eyal Zifman, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of pediatric gastroenterology service

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 28, 2023
• Study Start: July 16, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)