Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis
Low Level Light therapy (LLLT) has been used for tissue healing in many mucosal diseases that involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in particular. Likewise IBD is characterized by chronic tissue inflammation, tissue damage and ulcerations in various extents. Therefore we hypothesize that LLLT might be effective in treating IBD and the Photopill capsule was developed for this purpose.
An open-label, interventional, clinical trial was designed for assessment of the safety and feasibilty of the Photopill capsule treatment in patients with mild to moderate Ulcerative Proctitis.
Primary endpoints being: safety reflected by the number and severity of adverse events and mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition.
Furthermore clinical and biochemical parameters are monitored during the study.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients With Ulcerative Proctitis|
- Adverse events [ Time Frame: day 0-42 ] [ Designated as safety issue: Yes ]Any adverse events reported by subjects
- Inflammatory markers [ Time Frame: day 0,14,28,42 ] [ Designated as safety issue: No ]serum CRP, serum Hb/Ht, fecal Calprotectin
- Clinical Questionnaires [ Time Frame: day 0,14,28,42 ] [ Designated as safety issue: No ]Simple Clinical Colitis Activity Index Partial Mayo score
- Mucosal appearance at sigmoidoscopy [ Time Frame: week 0,14,28.42 ] [ Designated as safety issue: Yes ]endoscopic disease activity Mayo score and possible damage by device
|Study Start Date:||January 2013|
|Study Completion Date:||June 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
|Experimental: Photopill treatment||
Device: Photopill treatment
Other Name: Photopill
Please refer to this study by its ClinicalTrials.gov identifier: NCT01837615
|Academic Medical Center|
|Amsterdam, North Holland, Netherlands, 1105 AZ|
|Principal Investigator:||Geert R D'Haens, MD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|