20 Dec Alicaforsen
Posted at 12:39h
in Studies
A randomised, double-blind, placebo controlled trial of the safety and efficacy of topical Alicaforsen enema in active, chronic, antibiotic-refractory primary idiopathic pouchitis.
Inclusion criteria:
- Active disease
- ≥6 stools/day OR ≥3 stools above post-IPPA baseline
- PDAI score ≥7
- Endoscopic score ≥2
- Chronicity, i.e. symptomatic for at least 4 weeks continuously prior to randomisation
- Antibiotic refractory, i.e. active disease despite 2 week course of antibiotics (must be stopped at least 4 weeks before randomisation)
Exclusion Criteria:
- History of faecal transplant
- Cuffitis (patients with both pouchitis and cuffitis may be enrolled)
- Crohn’s Disease of the pouch defined as
- Complex perianal/pouch fistula and/or
- Extensive pre-pouch ileitis with deep ulceration
Medications:
| Permitted | Not Permitted |
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*Previous alicaforsen use is permitted but course must have been completed at least 12 weeks prior to screening.*
If you are interested in participating in this study either as a patient or an investigator, please contact initiativeibd@gmail.com
