Open Label Study to Assess Safety & Efficacy of QD for Induction of Remission in Pediatric Patien… (NCT06777706) | Clinical Trial Compass
CompletedNot Applicable
Open Label Study to Assess Safety & Efficacy of QD for Induction of Remission in Pediatric Patients with UC
Israel20 participantsStarted 2023-01-01
Plain-language summary
To date, there are no reports on the use of QD in pediatric patients with UC. There is a great need to increase the repertoire of anti-inflammatory interventions for remission induction, especially in children given the notorious side effects of steroids on growth. Importantly, no prescription is needed to acquire QD, as this is a food supplement that can be purchased over the counter. We wish to assess the efficacy and safety of QD as induction therapy in pediatric patients with mild-moderate active UC.
Who can participate
Age range
4 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Established diagnosis of UC for at least one month based on accepted criteria15.
. Age 4-17.9 years old (inclusive).
. Weight ≥ 15kg
. PUCAI 10-60 at enrollment (reflecting mild-moderate UC).
. If a patient is receiving oral 5-ASA, the dose must be stable for at least 4 weeks prior to inclusion.
. If patient is receiving immunomodulator medication (azathioprine or 6- mercaptopurine), dose must be stable for at least 3 months prior to inclusion.
. If a patient is on topical 5-ASA (suppositories or enema) the dose must be stable for at least 2 weeks prior to inclusion and will not be altered throughout the 6-week study period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is already completed, would it be possible to see any of the results or findings from it, and could those results help guide my child's treatment options for ulcerative colitis?
2This was an open-label study, meaning all participants knew what treatment they were receiving — how might that affect how confident we should be in the safety and efficacy data when thinking about this treatment for my child?
3The trial measured clinical remission at 6 weeks as its main goal — is 6 weeks a realistic or meaningful timeframe to judge whether this treatment is working for pediatric UC, and what happens if remission isn't achieved by then?
4This trial was listed as Phase NA, which is unusual — can you help me understand what that means for how much is actually known about the safety and effectiveness of this specific treatment approach in children?
5Are there standard treatments for pediatric ulcerative colitis that we should consider trying first before looking at options studied in trials like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.