The Assessment of Infrared Treatment for Crohn's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShmuel Kivity, MD
About this trial
The goal of this clinical trial is to test the safety and efficacy of far Infra-red (fIR) therapy in Crohn's disease patients.
The main questions it aims to answer are:
1. Is infrared therapy safe for treating Crohn's disease patients? 2. Is infrared therapy effective for treating Crohn's disease?
Participants will be asked to attend 10 treatments of fIR therapy, provide stool and blood samples and answer questionnaires.
Researchers will compare between 4 treatments: three intensities of fIR therapy and placebo treatment to explore which intensity is most effective for treating Crohn's disease.
Eligibility criteria
Qualifiers
An established Crohn's disease
18 < age < 80
No therapy or on constant medicinal regimen throughout the study period: mesalamine at least 6 weeks, or steroids at least 2 weeks, or immunomodulatory drugs at least 12 weeks or biologics at least 12 weeks, medical cannabis at least 2 weeks before the study.
CD patients will be included if their symptoms score >4 on the Harvey-Bradshaw index (HBI) score and/or fecal calprotectin level > 150 ug/gr.
Disqualifiers
BMI greater than 30 Kg/m2
Any proven current infection such as Clostridioides difficile infection, positive stool culture, or parasites.
Inability to sign informed consent and complete study protocol
Pregnancy
Trial design
Treatments tested in this trial
- High level photobiomodulation treatment in the infrared (IR) range.
- Medium level photobiomodulation treatment in the far infrared (IR) range
- Low level photobiomodulation treatment in the far infrared (IR) range
- Photobiomodulation sham treatment
Treatment groups
40 Participants
are divided into 4 treatment groupsSponsors and collaborators
Shmuel Kivity, MD
Lead sponsor
Tel-Aviv Sourasky Medical Center
Sponsor institution
Source ClinicalTrials.gov