Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis (Photopill)
|ClinicalTrials.gov Identifier: NCT01837615|
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : June 23, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Proctitis||Device: Photopill treatment||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients With Ulcerative Proctitis|
|Study Start Date :||January 2013|
|Primary Completion Date :||May 2015|
|Study Completion Date :||June 2015|
|Experimental: Photopill treatment||
Device: Photopill treatment
Other Name: Photopill
- Adverse events [ Time Frame: day 0-42 ]Any adverse events reported by subjects
- Inflammatory markers [ Time Frame: day 0,14,28,42 ]serum CRP, serum Hb/Ht, fecal Calprotectin
- Clinical Questionnaires [ Time Frame: day 0,14,28,42 ]Simple Clinical Colitis Activity Index Partial Mayo score
- Mucosal appearance at sigmoidoscopy [ Time Frame: week 0,14,28.42 ]endoscopic disease activity Mayo score and possible damage by device
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)|