Photopill Treatment in Healthy Volunteers

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)4 enrolled

Overview

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 Unpublished study (Melzer, Ben-Yehuda et al.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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcerated Mucosa of Colon

Interventions

Photopill treatmentDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Academic Medical Center Amsterdam, department of Gastroenterology

Amsterdam, North Holland, Netherlands

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.