The Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Healthy Volunteers, a Phase 1 Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Number of Participants with Adverse Events (Mucosal Aspect at 2nd sigmoidoscopy after 7-14 days) as a Measure of Safety and Tolerability
Study Overview
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Unpublished study (Melzer, Ben-Yehuda et al.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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Photopill treatment
Photopill treatment, 2 minutes per cm rectal mucosa (3cm) 10 times
Intervention: Photopill treatment (Device)
Outcomes
Primary Outcomes
Number of Participants with Adverse Events (Mucosal Aspect at 2nd sigmoidoscopy after 7-14 days) as a Measure of Safety and Tolerability
Time Frame: During Study period: day 0-14
Secondary Outcomes
No secondary outcomes reported
Investigators
Hanke Brandse
MD, Phd student, executive investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)