Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis
(UC), are chronic relapsing diseases that carry considerable impact on patients' quality of
life, including objective measures such as increased bowel movements, bleeding and fistulas
and more subjective measures such as abdominal pain and fatigue.
While the pathogenesis of IBD is thought to result from a deregulated immune response towards
microbial antigens in genetically predisposed people, various associations between
environmental factors and disease activity have been described. Currently, standard IBD
treatment relies on immune modulating drugs. However, such drugs may cause adverse effects,
and up to 35% of patients show no response and up to 80% fail to achieve remission.
The investigator would like to explore treating Crohn's disease with photobiomodulation in
the infrared (IR) range. Preliminary data suggest a positive effect of IR on Crohn's disease
activity, and would like to conduct a small scale, pilot clinical trial to further clinically
explore the safety and efficacy of this simple intervention.
Infrared is a safe, non-ionizing radiation spanning wavelengths from about 800 nanometers
(nm) to 1 millimeter (mm). The therapeutic effects of IR radiation were serendipitously
stumbled upon in the 1980s by NASA (National Aeronautics and Space Administration) scientists
who noticed improvement in skin lesions when assessing IR light for growing potatoes in
space. Since then, there has been a cautious advancement in assessing IR therapy for various
conditions and an increased understanding of some of the mechanisms underlying its effect.
Alongside its beneficial effect, infrared treatment is not associated with serious adverse
effects in general and with relation to fertility in particular. In fact, experimental data
suggest that far IR (fIR) is safe for treating various medical conditions including cancer,
diabetes and female infertility.
Due to the documented effects of IR therapy on inflammation and its favorable safety profile,
the investigator would like to assess its effect on Crohn's disease. A skilled staff member
will use a device emitting fIR radiation (8-10 microns) that is able to penetrate deep into
the body (up to at least 20 cm according to manufacturer). The device comprises a heating pad
that emits heat (up to 70 degree C) alongside fIR radiation.
Prior to treatment patient's bowel will be assessed by intestinal ultrasound (IUS) / CT/ MRI
to determine the location of inflammation in order to focalize treatment, but also to rule
out the presence of abscess and cysts.
All patients will undergo 10 sessions of 30 minutes fIR therapy at the IBD clinic of the Tel
Aviv Medical Center (TLVMC) by a trained and qualified staff member. Each abdominal quadrant
will receive a similar amount of time of exposure to the IR, except for the quadrant of the
inflamed intestine (usually the right lower quadrant) which will be exposed longer to the IR.
During the treatment, energy levels and skin temperature will be recorded at 10 minutes
intervals.
Patients responding to therapy (clinical response: ∆HBI≥3 and/or 50% reduction in
calprotectin), who did not achieve remission can continue for 10 more treatments. Patients
who are allocated to the control group will be eligible to transfer to the experimental group
after 10 sessions and receive 10 treatments with a high intensity fIR.
After the completion of treatments, at week 11, bowel thickness will be assessed again by
IUS, as well as biochemical and clinical indexes.
Clinical score will be assessed using the Harvey-Bradshaw index (HBI) at weeks: 0, 5, and 10.
Stool will be collected at weeks 0, 5 and 10 for fecal calprotectin analysis and for future
microbiome/proteomics analysis.
Blood will be collected at weeks 0, 5, and 10 for C reactive protein (CRP), complete blood
count (CBC), liver function tests, creatinine and lipase. Serum will be frozen for future
proteomics and inflammatory measures analysis. Total blood volume will be less than 20ml.
Patients will be asked to complete questionnaires evaluating their quality of life and
disease related symptoms and outcomes.
Side effects such as local skin thermal injury and blood tests abnormalities will be
documented. In case of local skin thermal injury, patients will be examined to determine
injury level, with recommendation to apply Aloe Vera paste and a follow-up call will be made
to document resolution of symptoms within 2 days.
Throughout the research period patients will be asked to maintain their usual lifestyle with
regards to nutrition and physical activity habits
Statistics Test results, clinical indexes and side effects will be compared between
experimental and control groups prior to- and post treatment. These measures will also be
analyzed within groups to compare pre- and post-treatment results.
Patients in both groups will be categorized by disease severity level (according to HBI) in
order to correlate disease severity with treatment efficacy. Patients will be randomized
according to disease severity in order to keep an equal rate of patients with mild clinical
disease activity upon recruitment.
All statistical analyses will be performed using SPSS version 23.0 for Windows. Demographic
characteristics of the population will be described by mean±SD for continuous variables,
while categorical variables will be displayed as a frequency table.
Normal distribution will be tested by Kolmogorov-Smirnov test. If normality is rejected,
non-parametric tests will be used.