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Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis (Photopill)

This study has been completed.
Photopill Medical Ltd
Information provided by (Responsible Party):
Hanke Brandse, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Identifier:
First received: April 18, 2013
Last updated: June 22, 2015
Last verified: June 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 Intervention Phase
Ulcerative Colitis
Device: Photopill treatment
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Adverse events [ Time Frame: day 0-42 ]
    Any adverse events reported by subjects

Secondary Outcome Measures:
  • 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

Enrollment: 8
Study Start Date: January 2013
Study Completion Date: June 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Photopill treatment Device: Photopill treatment
Other Name: Photopill


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with Ulcerative Proctitis (Mayo grade 1/2)

Exclusion Criteria:

  • Symptomatic hemorrhoids
  • Pregnant or lactating females
  • Patients that have used any experimental treatment within 8 weeks prior to Day 0
  • Patient that have used any biologics therapies or immunomodulation agents and/or steroids 4 weeks prior to Day 0
  • Rectal therapy 2 weeks prior to Day 0
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Please refer to this study by its identifier: NCT01837615

Academic Medical Center
Amsterdam, North Holland, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Photopill Medical Ltd
Principal Investigator: Geert R D'Haens, MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Responsible Party: Hanke Brandse, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Identifier: NCT01837615     History of Changes
Other Study ID Numbers: NL39583.018.12
Study First Received: April 18, 2013
Last Updated: June 22, 2015

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Ulcerative Colitis
Ulcerative Proctitis
Low Level Light Therapy

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Rectal Diseases processed this record on May 22, 2017