Ulcerated Mucosa of Colon
Conditions
Brief summary
Photo-bio-stimulation by Low Level Light therapy(LLLT) has demonstrated its clinical use in chemotherapy/radiotherapy oral mucositis. Unpublished study (Melzer, Ben-Yehuda et al. UEGW 2012) with the Photopill (LLLT) capsule treatment in mice showed a significant beneficial effect on the endoscopic severity of DSS-induced colitis in mice. Therefore a phase 1 trial is designed to assess the safety and feasibility of the Photopill treatment in healthy volunteers.
Interventions
DEVICEPhotopill treatment
2 courses of 5 Photopill treatments within 14 days. In each treatment, 3cm of rectal tissue will be exposed, 2 minutes per cm, to low level light therapy.
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who are generally healthy. * Signed informed consent.
Exclusion criteria
* Subjects with any known GI related symptoms complaints or GI diseases. * Subjects with cancer or other life threatening diseases or conditions. * Subjects with cardiovascular or pulmonary diseases. * Pregnant women. * Subjects who underwent any colon surgery. * Morbid Obesity (BMI \> 40). * Drug abuse or alcoholism. * Bed-ridden patient. * Any rectal therapy. * Participation in current clinical study or clinical study within 30 days prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events (Mucosal Aspect at 2nd sigmoidoscopy after 7-14 days) as a Measure of Safety and Tolerability | During Study period: day 0-14 |
Countries
Netherlands
Outcome results
None listed