Bleach and Urine Color in UC Patients Using 5ASA

NCT ID: NCT06013696

Last Updated: 2023-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-16

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Ulcerative Colitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Adding household bleach to urine sample

Intervention Type OTHER

Adding household bleach to urine sample

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.

Group Type PLACEBO_COMPARATOR

Adding household bleach to urine sample

Intervention Type OTHER

Adding household bleach to urine sample

Interventions

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Adding household bleach to urine sample

Adding household bleach to urine sample

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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eyal zifman

Head of pediatric gastroenterology service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eyal Zifman, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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MMC-22-198

Identifier Type: -

Identifier Source: org_study_id

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