Cure8 trial brief
Early-phase trials test whether new treatments are safe and show biological activity. This study measures fecal calprotectin, a biomarker of intestinal inflammation, so it could provide early signals about whether ND-12 alone or with H-6 affects gut inflammation compared with mesalazine.
Patients with active ulcerative colitis or persistent inflammatory diarrhoea might be eligible and could consider clinical-trial options if standard treatments are insufficient.
Adults with active ulcerative colitis or chronic inflammatory diarrhoea, gastroenterologists and IBD clinicians, and clinical researchers interested in early-phase IBD therapeutics and biomarker studies.
This registry record describes the planned study design, interventions, eligibility criteria, and the prespecified primary biomarker (fecal calprotectin). It does not report results or safety findings.
The investigational products ND-12 and H-6 are named in the protocol but are not described in detail here; mesalazine (an approved aminosalicylate) is included as a comparator.
The follow-up and assessment timing are short (14 days primary endpoint) and the planned enrollment is small (36 subjects), consistent with an early-phase study focused on preliminary biomarker and safety data.
If you are considering participation: the record lists inclusion/exclusion criteria, study location (The Second Affiliated Hospital of Nanjing Medical University), and contact/registration details on ClinicalTrials.gov. Discussing trial participation with your treating clinician is important to understand risks, logistics, and alternative treatments.
The entry is a trial registry record (early-phase 1, recruiting) and does not present results. ND-12 and H-6 are investigational here; the trial’s small size and short primary endpoint limit conclusions about long-term efficacy or safety. Participation would require meeting the listed eligibility and exclusion criteria.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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