The Assessment of Infrared Treatment for Crohn's Disease
Recruiting · NCT06146816 · Interventional (participants receive a specific treatment) · Lead sponsor: Shmuel Kivity, MD
View the official record on ClinicalTrials.gov →Interventions studied
High level photobiomodulation treatment in the infrared (IR) range.Low level photobiomodulation treatment in the far infrared (IR) rangeMedium level photobiomodulation treatment in the far infrared (IR) rangePhotobiomodulation sham treatment
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD.
- Presence of abscess and cysts in the liver/ kidneys or pancreas
- Evidence of an abdominal abscess or entero-enteric fistula.
- More than one CD luminal surgery or a small bowel length \< 1.5 meter
Where it is running
1 location listed.
- Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center - Tel Aviv, Israel