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

Phase 2

Completed

• Conditions: Ulcerative Colitis; Proctitis

• Registration Number: NCT01837615
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-18
• Study First Posted: 2013-04-23
• Primary Completion: 2015-05
• Status Verified: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse events	day 0-42	Any adverse events reported by subjects

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers	day 0,14,28,42	serum CRP, serum Hb/Ht, fecal Calprotectin
Clinical Questionnaires	day 0,14,28,42	Simple Clinical Colitis Activity Index Partial Mayo score
Mucosal appearance at sigmoidoscopy	week 0,14,28.42	endoscopic disease activity Mayo score and possible damage by device

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, North Holland, Netherlands