Desloratadine added to mesalamine for adults with mild to moderate ulcerative colitis
Official title: Efficacy and Safety of Desloratadine as Adjuvant Therapy in Patients With Ulcerative Colitis
Run by Tanta University · NCT07333716 · Data updated 2026-11-12
This trial will test whether adding the antihistamine desloratadine to standard mesalamine therapy helps reduce inflammation and disease activity in adults with mild to moderate ulcerative colitis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Shibīn al Kawm, Menofia) |
| Status | Recruiting |
| Started | January 26, 2026 |
| Main results expected | February 2027 |
| Study ends | March 2027 |
| Registry record updated | January 29, 2026 |
| Trial ID | NCT07333716 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 to 65 with active mild to moderate ulcerative colitis who are currently treated with mesalamine are the intended participants.
✕Probably not a fit
Patients with severe ulcerative colitis, recent or current treatment with systemic/rectal steroids, immunosuppressants or biologics, significant liver or kidney abnormalities, pregnancy or lactation, prior colectomy, other inflammatory diseases, or known allergy to desloratadine are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial gives adult patients with active mild to moderate ulcerative colitis desloratadine in addition to their prescribed mesalamine to evaluate safety and therapeutic effect on inflammation and disease activity. Participants are adults aged 18–65 who are already being treated with 5-aminosalicylic acid and do not have severe disease, recent biologic or immunosuppressant use, or major organ dysfunction. The trial is based on preclinical data suggesting desloratadine has anti-inflammatory and antioxidant effects through mast cell regulation and histamine inhibition. Outcomes will focus on clinical disease activity measures and safety signals compared to standard therapy alone.
Why it matters
Potential benefit: If effective, adding desloratadine could reduce colonic inflammation and improve symptoms for patients with mild to moderate ulcerative colitis when used alongside mesalamine.
How similar studies have gone: Preclinical models showed benefit of desloratadine for experimental ulcerative colitis, but clinical evidence for antihistamines in UC is limited and this approach remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Both male and female sex. * patients with age ranged from 18 to 65. * patients with active mild and moderate ulcerative colitis according to American College of Gastroenterology (ACG) Clinical Guideline. * Patients treated with 5-aminosalisylic acid (mesalamine). Exclusion Criteria: * Patients with severe UC * Significant liver or kidney function abnormalities * Pregnant or lactating females * Treatment with systemic or rectal steroids * Treatment with immunosuppressant or biological therapies * Known allergy to desloratadine or any ingredient in the formulation * Patients with other inflammatory diseases * Patients with history of colon cancer * Patients with complete or partial colectomy
Where it's running
-
Menofia university Hospitals
Shibīn al Kawm, Menofia, Egypt Recruiting
Study contacts
- Principal investigator: Romisaa R Abd Alnapy — Tanta University
- Study coordinator: Romisaa R Abd Alnapy
- Email: PG_182624@pharm.tanta.edu.eg
- Phone: +201288667650
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.