A common antibiotic may help Crohn's patients get more out of biologic therapy
NCT ID NCT05599347
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial tests whether a short course of azithromycin, taken before starting anti-TNF therapy, can reduce the body's tendency to develop antibodies against the biologic drug. Antibodies can make the treatment less effective over time. The study enrolls adults with Crohn's disease who are about to begin anti-TNF therapy and compares azithromycin to a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- azithromycin pill
- What this could lead to
- If it works, this could point toward a simple way to make anti-TNF therapy more effective and durable for people with Crohn's disease.
- What could go wrong
- This is a mid-stage trial, so the approach may not prove effective. Azithromycin can cause side effects like gastrointestinal upset or antibiotic resistance.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ability to provide written informed consent prior to any study procedures and willing and able to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study period. * Aged 18 to 80 years of age, inclusive, at the time of signing the informed consent. * Diagnosis of CD with an onset of symptoms for a minimum of 3 months prior to Screening as determined by the investigator based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings. * Prior decision of starting infliximab or adalimumab therapy (including biosimilar drugs). * Thiopurine and corticosteroid co-therapy will be permitted. Exclusion Criteria: * Inclusion in another interventional study * Patients who cannot provide informed consent and do not have a legal guardian * Patients with perianal involvement who are expected to require antibiotic therapy for their disease * Patients on chronic antibiotic therapy due to any cause * Patients with ongoing fluid collection/abscess either internal or perianal * Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device * Prolonged QTc interval or conditions leading to additional risk for QT prolongation * Chronic kidney disease stage 5 (GFR \< 10) * Crohn's Disease complication requiring surgical treatment * Planned/ongoing methotrexate co-therapy * Fecal microbiota transplantation within 8 weeks prior to randomization * Participant has any disorder that, in the opinion of the investigator, may compromise the ability to participate in the study * Pregnancy * Patients who received azithromycin therapy in the previous year (we will not exclude prior use of other antibiotic therapy) * Patients who received any antibiotic treatment within 4 weeks prior to randomization * Re-induction of the same anti-TNF medication * Patients who are on chronic therapy which cannot be withheld in one of these medications: colchicine, phenytoin, and digoxin
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Bnei Zion
RECRUITINGHaifa, Israel
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Carmel Medical Center
RECRUITINGHaifa, Israel
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Hadassah Medical Center
RECRUITINGJerusalem, Israel
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Rabin Medical Center
RECRUITINGPetah Tikva, Israel
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Rambam Health Care Campus
RECRUITINGHaifa, Haifa District, Israel
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Shaare Zedek
RECRUITINGJerusalem, Israel
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Soroka University Medical Center
RECRUITINGBeersheba, Israel
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Wolfson Medical Center
RECRUITINGHolon, Israel
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Zvulun
RECRUITINGKiryat Bialik, Israel
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