Clinical Trial: Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients With Ulcerative Proctitis

Brief Summary:

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.


Detailed Summary:
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Current Primary Outcome: Adverse events [ Time Frame: day 0-42 ]

Any adverse events reported by subjects


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Dates:
Date Received: April 18, 2013
Date Started: January 2013
Date Completion:
Last Updated: June 22, 2015
Last Verified: June 2015