A Phase 2 interventional study of Photopill treatment in Ulcerative Colitis and Proctitis, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-06-23.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Phase 2, Interventional, and Treatment
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's enrollment of 8 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Photopill treatment
Also known as: Photopill
Adverse events
Any adverse events reported by subjects
Time frame: day 0-42
Inflammatory markers
serum CRP, serum Hb/Ht, fecal Calprotectin
Time frame: day 0,14,28,42
Clinical Questionnaires
Simple Clinical Colitis Activity Index Partial Mayo score
Time frame: day 0,14,28,42
Mucosal appearance at sigmoidoscopy
endoscopic disease activity Mayo score and possible damage by device
Time frame: week 0,14,28.42
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) →