Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)
Stopped: The DSMB concluded that feasibility endpoints were reached in time for Week 4 but no participants receiving standard of care dietary treatment could be randomized based on the at-risk of the microbiome signature.
United States, Canada, Israel13 participantsStarted 2021-08-13
Plain-language summary
This is a multi-center, randomized, controlled open-label add-on design trial pilot study to evaluate the efficacy of personalized adjunctive antibiotic (azithromycin + metronidazole) therapy in pediatric subjects with mild to moderate Crohn's disease (CD) who have a microbiome profile associated with increased risk of early relapse. This an add-on design trial for subjects already receiving standard of care therapy to induce remission; there will be no placebos.
Who can participate
Age range
3 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
. Provision of signed and dated informed consent form (and assent form, as applicable);
. Stated willingness to comply with all study procedures and availability for the duration of the study;
. Male or female, aged 3 to 17 years;
. Diagnosed with CD according to standard clinical and histological criteria, within 36 months of week 0;
. Exhibiting mild to moderate symptoms of active disease, as determined by a Pediatric Crohn's Disease Activity Index (PCDAI) score \>10 (or \> 7.5 excluding the height item) and ≤37.5;
. Fecal calprotectin level \>=250 µg/g within 30 days prior to week 0 visit based on local measurement, if available, or to be arranged with lead site if an endoscopy is not performed within 30 days prior to week 0 visit.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Number of Participants With Sustained Remission
Timeframe: Week 52
2
Feasibility of Multinational Microbiome-randomized Trial
. Presence of stricturing, penetrating (intestinal or perianal) and/or fistulizing CD;
. Pregnancy or lactation;
. Have undergone intestinal resection;
. Positive Clostridium Difficile toxin;
. Treatment with another investigational drug or other intervention within 30 days before week 0;
. Risk factors for arrhythmia including history of prolonged corrected QT interval (QTc), hypokalemia or hypomagnesemia, resting bradycardia, or concurrent treatment with other drugs with potential for QT prolongation;