Photopill Treatment in Healthy Volunteers
Phase 1
Completed
- Conditions
- Ulcerated Mucosa of Colon
- Interventions
- Device: Photopill treatment
- Registration Number
- NCT01702662
- 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Unpublished study (Melzer, Ben-Yehuda et al.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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Photopill treatment Photopill treatment Photopill treatment, 2 minutes per cm rectal mucosa (3cm) 10 times
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Academic Medical Center Amsterdam, department of Gastroenterology
🇳🇱Amsterdam, Noord-Holland, Netherlands