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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis; Proctitis

Treatments: Device: Photopill treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01837615

NL39583.018.12

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Photopill treatment

Experimental group

Treatment:

Device: Photopill treatment