The evaluation of the safety and feasibilty of the Photopill capsule treatment in patients with Ulcerative Proctitis
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Safety evaluation of the device as determined by the number and severity of
Adverse Events in comparison to the baseline condition [Time Frame: Day 0 day
14, Day 28, Day 42 and unscheduled visits]
* Comparison between baseline sigmoidoscopy assessments of mucosal appearance
of the diseased area, and the follow up assessments of the diseased area,
according to the Mayo score [ Time Frame: Day 0, Day 14, Day 28 and Day 42]
* Comparison of Clinical Questionnaires partial Mayo score and SSCAI at
baseline and at day 42.
Secondary outcome
* Concentration of Inflammatory cells and mediators (cytokines, macrophages,
and lymphocytes) in the tissue, as detected by histological assessment of
biopsies taken from the diseased area . A comparison will be made between the
baseline measurements and follow up measurements of the diseased area [ Time
Frame: Day 0, Day 14, Day 28 and Day 42]
* Comparison of inflammatory markers in serum (CRP) and stool (calprotectin) as
collected at day 0 (baseline), 14, 28 and 42.
Background summary
Photobiostimulation, or Light therapy utilizes specific non-ionizing,
non-thermal light wavelengths irradiation, by low intensity lasers (LLLT) or
LED's, for the purpose of tissue healing for many skin and mucosal diseases
that involve wounds, ulcers and inflammation.
Phototherapy has a proven positive effect not only on skin diseases, but on
mucosal membrane as well. Such influence is described in several mucosal
conditions and oral chemotherapy-induced mucositis in particular.
IBD is characterized by chronic tissue inflammation, tissue damage and
ulcerations in various extents, and as such show considerable resemblance to
many skin and mucosal conditions that are treated by light.
This observation suggest that photobiostimulation can be effective in treating
inflammatory gastrointestinal (GI) diseases and IBD in particular.
Photopill capsule has been developed specially for the treatment of IBD.
Study objective
The evaluation of the safety and feasibilty of the Photopill capsule treatment
in patients with Ulcerative Proctitis
Study design
Open-label, interventional, self-controlled, clinical study
Intervention
After the rectum of the patient is cleaned with a Saline enema, the Photopill
suppository capsule, mounted on a flexible rectal tube, will be inserted to the
rectum to the pre-determined distance(based on sigmoidoscopy data). Finally the
capsule will be activated.
Every 2 minutes, the rectal tube will be pulled out 1 cm distal to the previous
location, and will be held in the new location for 2 minutes. The process will
be repeated until all the diseased area is covered.
In total 10 treatment sessions will take place within the first 28 days.
Follow-up will proceed untill day 42, when the last of the 4 sigmoidoscopies
will be performed,
Study burden and risks
The main risk factor of the capsule is thermal damage of the intestinal mucosa
due to light therapy.
This factor was examined during the pre-clinical studies in pigs and found to
be non-significant.
Another side effect may be tissue erosion due to the insertion of the
suppository capsule.
The rectal treatment sessions might be experienced as unpleasant and the same
will possibly account for the repeating sigmoidoscopies.
New Industrial Park Bldg 7
Yokneam Illit 20692
IL
New Industrial Park Bldg 7
Yokneam Illit 20692
IL
Listed location countries
Age
Inclusion criteria
* Diagnosed with Ulcerative Proctitis (Naïve or failing on stable dose of 5-ASA agents 8 weeks prior to day 0).
* Visible evidence for Ulcerative Proctitis in the rectum at the relevant treated area.
* Mild to moderate Ulcerative Proctitis Mayo grade 1 or 2
* Able and willing to travel 3 times a week to the clinic.
* Subject willing to sign an Informed Consent
* 18
Exclusion criteria
* Symptomatic hemorrhoids
* Pregnant or lactating females
* Patients that have used any experimental treatment within 8 weeks prior to Day 0
* Patients that have used any biologics therapies and/or steroids 4 weeks prior to Day 0
* Rectal therapy 2 weeks prior to Day 0
* Dose change in immunosuppression (azathioprine, 6-MP) in the previous 3 months
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39583.018.12 |